Healthy Volunteer StudyPhase 1NCT06118385

Study Investigating the Safety, Tolerability, PK and Food Effect of BEN8744.

A Phase 1 study testing BEN8744 in people with Healthy Volunteer Study, run by BenevolentAI Bio at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

BEN8744 is an experimental new medicine for treating inflammatory bowel diseases such as Ulcerative Colitis. The study will test single and repeated oral doses of BEN8744 or placebo. BEN8744 is a first in human study, so will start with a small dose and the dose will be increased as the study progresses. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer Study
What is being tested?: BEN8744
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 1 siteUnited Kingdom
Study dates: 30 Aug 2023to 18 Mar 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female healthy volunteer in good health
Aged 18-65 years
Body mass index 18.0-30.9 and weight ≥ 50 kg

Who cannot join

1. Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Hammersmith Medicines Research
London

Other trials in United Kingdom

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Phase 1 First-in-human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single- and Multiple-ascending Doses of BEN8744 in Healthy Subjects.

BEN8744 is an experimental new medicine for treating inflammatory bowel diseases such as Ulcerative Colitis.

The study will test single and repeated oral doses of BEN8744 or placebo. BEN8744 is a first in human study, so will start with a small dose and the dose will be increased as the study progresses. The goal is to find out its side effects and blood levels when taken by mouth and whether food affects the blood levels.

This is a 3-part study (Parts A, B and C) in up to 108 healthy people, aged 18-65.

Part A, will include up to 64 participants, single doses of BEN8744 or placebo. They'll take about 2 weeks to finish the study, stay on the ward for 4 nights and 5 days in a row and make 2 outpatient visits.

Part B, will include up to 12 participants, single doses of BEN8744 with and without food. They'll take up to 3 weeks to finish the study, stay on the ward for 4 nights and 5 days in a row on 2 occasions, and make 2 outpatient visits.

Part C will include up to 32 participants repeat doses of the BEN8744 or placebo for 14 days. They'll take about 4 weeks to complete the study, stay on the ward for 17 nights and 18 days in a row and make 2 outpatient visits.

Read the detailed description

This first time in human, study will investigate the safety, tolerability, pharmacokinetics (PK) of BEN8744 after single and multiple ascending oral doses in healthy subjects, in both the fed and fasted state. The results of this study will be used to select doses for subsequent studies in patients. This is an exploratory study in healthy volunteers, with no anticipated therapeutic benefit to the participants; involvement of patients, service users or members of the public in the design of the trial is not appropriate.

Primary objectives Part A: To assess the safety and tolerability of single ascending oral doses of BEN8744 in healthy subjects Part B: To characterise the effect of food on the pharmacokinetic profile of at least 1 dose of BEN8744 Part C: To assess the safety and tolerability of multiple ascending oral doses of BEN8744 in healthy subjects

Secondary objectives Part A: To assess the PK profile of BEN8744 after single oral doses in healthy subjects Part B: To assess the safety and tolerability of a single dose of BEN8744 following high-fat food intake relative to fasting conditions in healthy subjects Part C: To assess the PK profile of BEN8744 after repeated oral doses in healthy subjects

Exploratory objective

Part B (and optional in Part C):

To measure BEN8744 in urine and determine renal clearance in healthy subjects. Exploratory characterisation of BEN8744 and its metabolites in plasma, urine, and faeces.

For part A

Up to 64 subjects, 5 cohorts + 3 optional, 6 active, 2 placebo.
Subjects will receive a single dose of BEN8744 or placebo, as capsules, after an overnight fast of at least 10 h.
At each dose level, 6 subjects will receive BEN8744 and 2 will receive matching placebo in an overall ratio of 3:1.
The starting dose for Group 1 is 2 mg BEN8744 or placebo. It is intended that subsequent cohorts will receive higher doses. The planned doses are:

A1- 2mg A2- 6mg A3- 20mg A4- 60mg A5- 100mg A6 (optional) - 120mg

For Part B

Up to 12 subjects, 1 cohorts + 1 optional, 2 sessions fasted/fed.
Each subject in Part B will have 2 study sessions (Sessions 1 and 2), in which they will receive a single dose of BEN8744, by mouth.
Each subject will receive BEN8744 after an overnight fast of at least 10 h in one session, and after an FDA high-fat breakfast (1,013 kcal, 59.2 g fat [of which 28.1 g saturated fat) in the other session; the order will be randomised 1:1.
A subject's doses will be separated by a washout of at least 7 days (or 5 half-lives as determined in Part A, whichever is longer).
Subjects dosed on the same day may be dosed at intervals of at least 10 min.

For Part C:

Up 32 subjects, 3 cohorts + 1 optional, 6 active, 2 placebo.
Each subject will receive daily doses of BEN8744 or placebo, by mouth, for 14 days.
Doses will be taken once or twice daily in the fasted state, unless emerging data indicate they should be taken in the fed state.
Part C will not start until at least 3 dose levels have been completed in Part A and may also be conducted in parallel with Part B.

Conditions: Healthy Volunteer Study
Being tested: BEN8744, Matching Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BEN8744Drug
Formulated powder in capsule for oral administration. Supplied as filled Size 0 Swedish Orange capsule. Doses: 2mg, 10mg and 40mg.
Matching PlaceboDrug
Formulated powder in capsule for oral administration. Supplied as filled Size 0 Swedish Orange capsule. Doses: 2mg, 10mg and 40mg.

Study groups in NCT06118385
Study group	Role	What they receive
Part A Dose 1	Experimental	Part A Dose 1 Single dose of 2 mg BEN8744 Receives: Drug: BEN8744
Part A Dose 2	Experimental	Part A Dose 2 Single dose of 6 mg BEN8744 Receives: Drug: BEN8744
Part A Dose 3	Experimental	Part A Dose 3 Single dose of 20 mg BEN8744 Receives: Drug: BEN8744
Part A Dose 4	Experimental	Part A Dose 4 Single dose of 60 mg BEN8744 Receives: Drug: BEN8744
Part A Dose 5	Experimental	Part A Dose 5 Single dose of 100 mg BEN8744 Receives: Drug: BEN8744
Part A Dose 6	Experimental	Part A Dose 6 Single dose of 120 mg BEN8744 Receives: Drug: BEN8744
Part A placebo	Experimental	Part A placebo Single dose of placebo Receives: Drug: Matching Placebo
Part B Dose 1 fed	Experimental	Part B Dose 1 Fed Single dose of BEN8744 after high-fat meal (Dose 30mg QD) Receives: Drug: BEN8744
Part B Dose 1 Fasted	Experimental	Part B Dose 1 Fasted Single dose of BEN8744 after 10 hours fasting (Dose 30mg QD) Receives: Drug: BEN8744
Part B Dose 2 Fed	Experimental	Part B Dose 2 Fed Single dose of BEN8744 after high-fat meal (Dose 50mg QD) Receives: Drug: BEN8744
Part B Dose 2 Fasted	Experimental	Part B Dose 2 Fasted Single dose of BEN8744 after 10 hours fasting (Dose 50mg QD) Receives: Drug: BEN8744
Part C Dose 1	Experimental	Part C Dose 1 14 daily doses of BEN8744 (Dose 30mg BID) Receives: Drug: BEN8744
Part C Dose 2	Experimental	Part C Dose 2 14 daily doses of BEN8744 (Dose 50mg BID) Receives: Drug: BEN8744
Part C placebo	Experimental	Part C placebo 14 daily doses of placebo Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part A)
The investigator/designee scored the participant's level of alertness on a scale of 0 (absence of response to stimulus) to 5 (readily responsive to the subject's name in a normal tone) in each of 4 components (responsiveness, speech, facial expression, eyes). The composite score corresponds to the lowest score for any component. The sum is the sum of the 4 component scores, ranging from 9 to 20. Positive change in composite score or sum is a better outcome; negative change is a worse outcome.
Measured: From Baseline (predose on Day 1) through 72 hours postdose
Change From Baseline in Visual Analogue Scale (VAS) (Part A)
The participant graded level of alertness by placing a mark on a linear scale from 0 (very alert) to 100 (very drowsy). Negative change is a better outcome; positive change is a worse outcome.
Measured: From Baseline (predose on Day 1) through 72 hours postdose
Cmax (PK Part B)
Maximum (peak) plasma concentration. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Tmax (PK Part B)
Time to reach maximum (peak) plasma concentration. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
AUC24 (PK Part B)
Area under the plasma concentration-time curve from time 0 to 24 hours postdose. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours postdose in each of the 2 treatment periods (fasted and fed)
AUC72 (PK Part B)
Area under the plasma concentration-time curve from time 0 to 72 hours postdose. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
AUClast (PK Part B)
Area under the plasma concentration-time curve from time zero to time of last measurable concentration. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
AUCinf (PK Part B)
Area under the plasma concentration-time curve from time 0 to infinity. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
t1⁄2 (PK Part B)
Terminal half-life. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Terminal Rate Constant (PK Part B)
Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
CL/F (PK Part B)
Systemic clearance relative to absolute bioavailability. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
VZ/F (PK Part B)
Apparent volume of distribution relative to absolute bioavailability. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
%AUCextrap (PK Part B)
Percentage of AUCinf extrapolated from time of last measurable concentration to infinity. Calculated from plasma concentrations collected at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part C)
The investigator/designee scored the participant's level of alertness on a scale of 0 (absence of response to stimulus) to 5 (readily responsive to the subject's name in a normal tone) in each of 4 components (responsiveness, speech, facial expression, eyes). The composite score corresponds to the lowest score for any component. The sum is the sum of the 4 component scores, ranging from 9 to 20. Positive change in composite score or sum is a better outcome; negative change is a worse outcome.
Measured: From Baseline (predose on Day 1) through 48 hours postdose
Change From Baseline in Visual Analogue Scale (VAS) (Part C)
The participant graded level of alertness by placing a mark on a linear scale from 0 (very alert) to 100 (very drowsy). Negative change is a better outcome; positive change is a worse outcome.
Measured: From Baseline (predose on Day 1) through 48 hours postdose
Columbia-Suicide Severity Rating Scale (C-SSRS) (Part C)
The C-SSRS is a questionnaire completed by the Investigator, who asks yes/no questions of the participant It I used to categorise risk levels based on the responses.
Measured: Completed during screening and on Days 17 and 24

Secondary outcomes (28)

Cmax (PK Part A)
Maximum (peak) plasma concentration. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Tmax (PK Part A)
Time to reach maximum (peak) plasma concentration. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUC24 (PK Part A)
Area under the plasma concentration-time curve from time 0 to 24 hours postdose. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours postdose
AUC72 (PK Part A)
Area under the plasma concentration-time curve from time 0 to 72 hours postdose. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUClast (PK Part A)
Area under the plasma concentration-time curve from time 0 to time of last measurable concentration. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUCinf (PK Part A)
Area under the plasma concentration-time curve from time 0 to infinity. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
%AUCextrap (PK Part A)
Percentage of AUCinf extrapolated from time of last measurable concentration to infinity. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
t1⁄2 (PK Part A)
Terminal half-life. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Terminal Rate Constant (PK Part A)
Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
CL/F (PK Part A)
Systemic clearance relative to absolute bioavailability. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
VZ/F (PK Part A)
Apparent volume of distribution relative to absolute bioavailability. Calculated from plasma concentrations at time points below.
Measured: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part B)
The investigator/designee scored the participant's level of alertness on a scale of 0 (absence of response to stimulus) to 5 (readily responsive to the subject's name in a normal tone) in each of 4 components (responsiveness, speech, facial expression, eyes). The composite score corresponds to the lowest score for any component. The sum is the sum of the 4 component scores, ranging from 9 to 20. Positive change in composite score or sum is a better outcome; negative change is a worse outcome.
Measured: From Baseline (predose on Day 1) through 72 hours postdose
Change From Baseline in Visual Analogue Scale (VAS) (Part B)
The participant graded level of alertness by placing a mark on a linear scale from 0 (very alert) to 100 (very drowsy). Negative change is a better outcome; positive change is a worse outcome.
Measured: From Baseline (predose on Day 1) through 72 hours postdose
Cmax (PK Part C)
Maximum (peak) plasma concentration. Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
Tmax (PK Part C)
Time to reach maximum (peak) plasma concentration. Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
Ctrough (PK Part C)
Trough plasma concentration. Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
AUCtau (PK Part C)
Area under the concentration-time curve across a dosing interval. Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
AUClast (PK Part C)
Area under the concentration-time curve from time 0 to the last measurable timepoint. Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
AUC72 (PK Part C)
Area under the plasma concentration-time curve from time 0 to 72 hours postdose. Calculated from plasma concentrations measured at the time points below.
Measured: At 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14
t1⁄2 (PK Part C)
Terminal half-life. Maximum (peak) plasma concentration. Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
AUCinf (PK Part C)
Area under the plasma concentration-time curve from time 0 to infinity. Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
%AUCextrap (PK Part C)
Percentage of AUCinf extrapolated from time of last measurable concentration to infinity. Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
Terminal Rate Constant (PK Part C)
Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
CLSS/F (PK Part C)
Systemic clearance relative to bioavailability at steady state (Day 14). Calculated from plasma concentrations measured at the time points below.
Measured: Plasma concentrations measured at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14
VZ/F (PK Part C)
Apparent volume of distribution relative to absolute bioavailability (Day 14). Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
Rac(AUCtau) (PK Part C)
Area under the concentration-time curve over the dosing interval on Day 14/area under the concentration-time curve over the dosing interval on Day 1 in AM. Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
Rac(Cmax) (PK Part C)
Maximum observed plasma concentration on Day 14/maximum observed plasma concentration on Day 1 in AM. Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
SR(AUC) (PK Part C)
Area under the concentration-time curve across a dosing interval on Day 14/area under the concentration-time curve from time 0 to infinity. Calculated from plasma concentrations measured before the morning dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20 and 24 hours after the morning dose on Day 1; before the morning dose on Days 3, 5, 7, 9, 11, and 13; and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14.
Measured: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 202318 Mar 2024

First posted7 Nov 2023
Study start30 Aug 2023
Primary completion14 Mar 2024
Study completion18 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The trial will be in 3 parts: Part A will investigate single ascending oral doses of BEN8744; Part B is a 2-way crossover assessment of the effect of food on the PK of BEN8744; and Part C will investigate multiple ascending oral doses of BEN8744
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06118385
Sponsor's protocol ID: BB-8744-1001
Status last verified: Apr 2025
First submitted: 22 Sep 2023
Last updated: 7 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
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See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Phase 1 First-in-human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single- and Multiple-ascending Doses of BEN8744 in Healthy Subjects.
ClinicalTrials.gov ID: NCT06118385
Acronym / sponsor ID: BB-8744-1001
Conditions: Healthy Volunteer Study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: BenevolentAI BioIndustry (pharma, biotech, devices)
Study start: 30 Aug 2023 (actual)
Primary completion: 14 Mar 2024 (actual)
Study completion: 18 Mar 2024 (actual)
First posted: 7 Nov 2023 (actual)
Results: Posted 7 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

BEN8744 is an experimental new medicine for treating inflammatory bowel diseases such as Ulcerative Colitis.

This is a 3-part study (Parts A, B and C) in up to 108 healthy people, aged 18-65.

Detailed description

Exploratory objective

Part B (and optional in Part C):

To measure BEN8744 in urine and determine renal clearance in healthy subjects. Exploratory characterisation of BEN8744 and its metabolites in plasma, urine, and faeces.

For part A

Up to 64 subjects, 5 cohorts + 3 optional, 6 active, 2 placebo.
Subjects will receive a single dose of BEN8744 or placebo, as capsules, after an overnight fast of at least 10 h.
At each dose level, 6 subjects will receive BEN8744 and 2 will receive matching placebo in an overall ratio of 3:1.
The starting dose for Group 1 is 2 mg BEN8744 or placebo. It is intended that subsequent cohorts will receive higher doses. The planned doses are:

A1- 2mg A2- 6mg A3- 20mg A4- 60mg A5- 100mg A6 (optional) - 120mg

For Part B

Up to 12 subjects, 1 cohorts + 1 optional, 2 sessions fasted/fed.
Each subject in Part B will have 2 study sessions (Sessions 1 and 2), in which they will receive a single dose of BEN8744, by mouth.
Each subject will receive BEN8744 after an overnight fast of at least 10 h in one session, and after an FDA high-fat breakfast (1,013 kcal, 59.2 g fat [of which 28.1 g saturated fat) in the other session; the order will be randomised 1:1.
A subject's doses will be separated by a washout of at least 7 days (or 5 half-lives as determined in Part A, whichever is longer).
Subjects dosed on the same day may be dosed at intervals of at least 10 min.

For Part C:

Up 32 subjects, 3 cohorts + 1 optional, 6 active, 2 placebo.
Each subject will receive daily doses of BEN8744 or placebo, by mouth, for 14 days.
Doses will be taken once or twice daily in the fasted state, unless emerging data indicate they should be taken in the fed state.
Part C will not start until at least 3 dose levels have been completed in Part A and may also be conducted in parallel with Part B.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 14
Model description: The trial will be in 3 parts: Part A will investigate single ascending oral doses of BEN8744; Part B is a 2-way crossover assessment of the effect of food on the PK of BEN8744; and Part C will investigate multiple ascending oral doses of BEN8744

Arm	Type	Receives
Part A Dose 1	Experimental	Drug: BEN8744Part A Dose 1 Single dose of 2 mg BEN8744
Part A Dose 2	Experimental	Drug: BEN8744Part A Dose 2 Single dose of 6 mg BEN8744
Part A Dose 3	Experimental	Drug: BEN8744Part A Dose 3 Single dose of 20 mg BEN8744
Part A Dose 4	Experimental	Drug: BEN8744Part A Dose 4 Single dose of 60 mg BEN8744
Part A Dose 5	Experimental	Drug: BEN8744Part A Dose 5 Single dose of 100 mg BEN8744
Part A Dose 6	Experimental	Drug: BEN8744Part A Dose 6 Single dose of 120 mg BEN8744
Part A placebo	Experimental	Drug: Matching PlaceboPart A placebo Single dose of placebo
Part B Dose 1 fed	Experimental	Drug: BEN8744Part B Dose 1 Fed Single dose of BEN8744 after high-fat meal (Dose 30mg QD)
Part B Dose 1 Fasted	Experimental	Drug: BEN8744Part B Dose 1 Fasted Single dose of BEN8744 after 10 hours fasting (Dose 30mg QD)
Part B Dose 2 Fed	Experimental	Drug: BEN8744Part B Dose 2 Fed Single dose of BEN8744 after high-fat meal (Dose 50mg QD)
Part B Dose 2 Fasted	Experimental	Drug: BEN8744Part B Dose 2 Fasted Single dose of BEN8744 after 10 hours fasting (Dose 50mg QD)
Part C Dose 1	Experimental	Drug: BEN8744Part C Dose 1 14 daily doses of BEN8744 (Dose 30mg BID)
Part C Dose 2	Experimental	Drug: BEN8744Part C Dose 2 14 daily doses of BEN8744 (Dose 50mg BID)
Part C placebo	Experimental	Drug: Matching PlaceboPart C placebo 14 daily doses of placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female healthy volunteer in good health
Aged 18-65 years
Body mass index 18.0-30.9 and weight ≥ 50 kg

Key exclusion criteria (1 listed)

1. Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BEN8744Formulated powder in capsule for oral administration. Supplied as filled Size 0 Swedish Orange capsule. Doses: 2mg, 10mg and 40mg.	Drug	Part A Dose 1, Part A Dose 2, Part A Dose 3, Part A Dose 4, Part A Dose 5, Part A Dose 6, Part B Dose 1 Fasted, Part B Dose 1 fed, Part B Dose 2 Fasted, Part B Dose 2 Fed, Part C Dose 1, Part C Dose 2
Matching PlaceboFormulated powder in capsule for oral administration. Supplied as filled Size 0 Swedish Orange capsule. Doses: 2mg, 10mg and 40mg.	Drug	Part A placebo, Part C placebo

Primary outcome

Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part A)
Time frame: From Baseline (predose on Day 1) through 72 hours postdose
The investigator/designee scored the participant's level of alertness on a scale of 0 (absence of response to stimulus) to 5 (readily responsive to the subject's name in a normal tone) in each of 4 components (responsiveness, speech, facial expression, eyes). The composite score corresponds to the lowest score for any component. The sum is the sum of the 4 component scores, ranging from 9 to 20. Positive change in composite score or sum is a better outcome; negative change is a worse outcome.
Change From Baseline in Visual Analogue Scale (VAS) (Part A)
Time frame: From Baseline (predose on Day 1) through 72 hours postdose
The participant graded level of alertness by placing a mark on a linear scale from 0 (very alert) to 100 (very drowsy). Negative change is a better outcome; positive change is a worse outcome.
Cmax (PK Part B)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Maximum (peak) plasma concentration. Calculated from plasma concentrations at time points below.
Tmax (PK Part B)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Time to reach maximum (peak) plasma concentration. Calculated from plasma concentrations at time points below.
AUC24 (PK Part B)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours postdose in each of the 2 treatment periods (fasted and fed)
Area under the plasma concentration-time curve from time 0 to 24 hours postdose. Calculated from plasma concentrations at time points below.
AUC72 (PK Part B)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Area under the plasma concentration-time curve from time 0 to 72 hours postdose. Calculated from plasma concentrations at time points below.
AUClast (PK Part B)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Area under the plasma concentration-time curve from time zero to time of last measurable concentration. Calculated from plasma concentrations at time points below.
AUCinf (PK Part B)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Area under the plasma concentration-time curve from time 0 to infinity. Calculated from plasma concentrations at time points below.
t1⁄2 (PK Part B)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Terminal half-life. Calculated from plasma concentrations at time points below.
Terminal Rate Constant (PK Part B)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Calculated from plasma concentrations at time points below.
CL/F (PK Part B)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Systemic clearance relative to absolute bioavailability. Calculated from plasma concentrations at time points below.
VZ/F (PK Part B)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Apparent volume of distribution relative to absolute bioavailability. Calculated from plasma concentrations at time points below.
%AUCextrap (PK Part B)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed)
Percentage of AUCinf extrapolated from time of last measurable concentration to infinity. Calculated from plasma concentrations collected at time points below.
Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part C)
Time frame: From Baseline (predose on Day 1) through 48 hours postdose
The investigator/designee scored the participant's level of alertness on a scale of 0 (absence of response to stimulus) to 5 (readily responsive to the subject's name in a normal tone) in each of 4 components (responsiveness, speech, facial expression, eyes). The composite score corresponds to the lowest score for any component. The sum is the sum of the 4 component scores, ranging from 9 to 20. Positive change in composite score or sum is a better outcome; negative change is a worse outcome.
Change From Baseline in Visual Analogue Scale (VAS) (Part C)
Time frame: From Baseline (predose on Day 1) through 48 hours postdose
The participant graded level of alertness by placing a mark on a linear scale from 0 (very alert) to 100 (very drowsy). Negative change is a better outcome; positive change is a worse outcome.
Columbia-Suicide Severity Rating Scale (C-SSRS) (Part C)
Time frame: Completed during screening and on Days 17 and 24
The C-SSRS is a questionnaire completed by the Investigator, who asks yes/no questions of the participant It I used to categorise risk levels based on the responses.

28 secondary outcomes

Cmax (PK Part A)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Tmax (PK Part A)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUC24 (PK Part A)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours postdose
AUC72 (PK Part A)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUClast (PK Part A)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUCinf (PK Part A)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
%AUCextrap (PK Part A)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
t1⁄2 (PK Part A)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Terminal Rate Constant (PK Part A)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
CL/F (PK Part A)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
VZ/F (PK Part A)
Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part B)
Time frame: From Baseline (predose on Day 1) through 72 hours postdose
Change From Baseline in Visual Analogue Scale (VAS) (Part B)
Time frame: From Baseline (predose on Day 1) through 72 hours postdose
Cmax (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
Tmax (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
Ctrough (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
AUCtau (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
AUClast (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
AUC72 (PK Part C)
Time frame: At 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14
t1⁄2 (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
AUCinf (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
%AUCextrap (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
Terminal Rate Constant (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
CLSS/F (PK Part C)
Time frame: Plasma concentrations measured at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 12.5, 13, 14, 15, 16, 20, 24, 36, 48, and 72 hours after the morning dose on Day 14
VZ/F (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
Rac(AUCtau) (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
Rac(Cmax) (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)
SR(AUC) (PK Part C)
Time frame: Plasma concentrations measured from predose on Day 1 through 72 hours after Day 14 dose (see specific time points above)

Results and safety

Results posted to the registry on 7 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A Placebo	12	12
Part A Dose 1	6	6
Part A Dose 2	6	6
Part A Dose 3	6	6
Part A Dose 4	6	6
Part A Dose 5	6	6
Part A Dose 6	6	6
Part B Dose 1	6	6
Part B Dose 2	6	4
Part C Placebo	4	4
Part C Dose 1	6	6
Part C Dose 2	6	6

Primary outcome: Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part A)

Time frame: From Baseline (predose on Day 1) through 72 hours postdose. Mean (Standard Deviation). Unit: score on a scale (change)

Measure	Part A Placebo n = 12	Part A Dose 1 n = 6	Part A Dose 2 n = 6	Part A Dose 3 n = 6	Part A Dose 4 n = 6	Part A Dose 5 n = 6	Part A Dose 6 n = 6
Composite score (0.25 hour)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Composite score (0.5 hour)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Composite score (1 hour)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Composite score (2 hours)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Composite score (3 hours)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Composite score (4 hours)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Composite score (6 hours)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Composite score (8 hours)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)

Primary outcome: Change From Baseline in Visual Analogue Scale (VAS) (Part A)

Time frame: From Baseline (predose on Day 1) through 72 hours postdose. Mean (Standard Deviation). Unit: mm on a 100-mm line (change)

Measure	Part A Placebo n = 12	Part A Dose 1 n = 6	Part A Dose 2 n = 6	Part A Dose 3 n = 6	Part A Dose 4 n = 6	Part A Dose 5 n = 6	Part A Dose 6 n = 6
Score (0.25 hour)	1.8 (4.59)	-3.0 (7.29)	0.5 (4.32)	3.7 (7.37)	-1.2 (1.94)	-5.8 (7.73)	-5.5 (19.42)
Score (0.5 hour)	0.3 (5.80)	0.5 (12.76)	3.8 (17.29)	2.7 (13.98)	1.0 (3.79)	-2.8 (9.52)	-3.3 (35.30)
Score (1 hour)	1.9 (4.64)	-8.2 (13.06)	14.8 (30.64)	6.3 (12.86)	1.8 (7.14)	-2.0 (7.38)	-2.0 (37.83)
Score (2 hours)	6.7 (12.03)	-9.3 (12.69)	6.2 (8.33)	2.0 (12.93)	1.3 (5.85)	0.7 (8.52)	4.0 (38.76)
Score (3 hours)	3.5 (9.11)	-10.3 (22.00)	3.7 (6.59)	4.3 (17.20)	-1.2 (6.62)	3.3 (7.66)	-4.7 (30.69)
Score (4 hours)	1.2 (11.44)	-11.2 (14.33)	3.7 (8.52)	1.2 (14.66)	-2.3 (4.50)	6.8 (10.46)	5.0 (28.87)
Score (6 hours)	1.8 (7.00)	-14.3 (15.91)	3.5 (7.23)	4.3 (27.98)	7.0 (19.83)	1.5 (17.03)	-2.2 (34.74)
Score (8 hours)	2.1 (9.58)	3.7 (30.06)	0.0 (2.37)	7.3 (24.36)	-2.2 (7.68)	8.0 (17.20)	-7.8 (28.53)

Primary outcome: Cmax (PK Part B)

Time frame: Plasma concentrations measured predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose in each of the 2 treatment periods (fasted and fed). Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Part B Dose 1 Fasted n = 5	Part B Dose 1 Fed n = 6	Part B Dose 2 Fasted n = 5	Part B Dose 2 Fed n = 5
Value	76.7 (41.4)	88.8 (33.2)	265 (50.0)	173 (56.3)

Primary outcome: Tmax (PK Part B)

Measure	Part B Dose 1 Fasted n = 5	Part B Dose 1 Fed n = 6	Part B Dose 2 Fasted n = 5	Part B Dose 2 Fed n = 5
Value	1.08 (1.00 to 3.00)	2.02 (1.00 to 3.00)	1.00 (0.500 to 2.03)	3.00 (2.02 to 4.00)

28 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the signing of the informed consent form through 10 days after the last dose (Day 11 in Parts A and B, Day 24 in Part C). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A Placebo	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Part A Dose 1	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part A Dose 2	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part A Dose 3	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part A Dose 4	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part A Dose 5	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part A Dose 6	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part B Dose 1 Fasted	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part B Dose 1 Fed	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part B Dose 2 Fasted	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Part B Dose 2 Fed	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Part C Placebo	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Part C Dose 1	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part C Dose 2	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Denisa Wilkes principal investigator

Hammersmith Medicine Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BEN8744 in people with Healthy Volunteer Study, run by BenevolentAI Bio at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Observer's Assessment of Alertness/Sedation Scale (OAAS/S) (Part A) (time frame: From Baseline (predose on Day 1) through 72 hours postdose). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06118385.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.