Healthy ParticipantsPhase 1NCT04731922

A Study of TAK-510 in Healthy Adults

A Phase 1 study testing TAK-510 in people with Healthy Participants, run by Takeda at 2 sites in United States.

Completed

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

Trial summary

This is a study of TAK-510 for people with symptoms of feeling sick (nausea) or being sick (vomiting). The main aims of the study are to check if healthy adults have side effects from TAK-510 and to check how much TAK-510 they can receive without getting side effects from it. The study will be in 3 parts. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: TAK-510
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 124 participants
Where: 2 sitesUnited States
Study dates: 3 Feb 2021to 24 Jul 2022
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing and throughout the study.
Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2) at the screening visit.

Who cannot join

Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody/antigen, at the screening visit.
Had major surgery or donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the screening visit.
Unable to refrain from or anticipates using all medications including herbal medicines beginning approximately 7 days before administration of the first dose of study drug, throughout the study until 2 days after discharge.
Unable to refrain from or anticipates using marijuana or cannabis-containing products beginning approximately 7 days before administration of the first dose of study drug, throughout the study until after the last PK dose.
Has had a previous major psychotic disorder.
Has an average semirecumbent blood pressure (BP) less than 90/60 millimeter of mercury (mmHg) or greater than 140/90 mmHg from screening to predose, inclusive. Any assessments on Day -1, where 2 consecutive time point values do not meet this criterion must be discussed with the medical monitor for approval.

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Has orthostatic hypotension defined as a decrease in systolic BP >=20 mmHg or a decrease in diastolic BP >=10 mmHg at approximately 3 minutes of standing when compared with BP from the semirecumbent position, at screening to predose assessments, inclusive. In asymptomatic participants, any assessments after screening that do not meet this criterion may be repeated after the participant has remained in the semirecumbent or supine position for 15 minutes. If the repeat assessment is exclusionary based on the above criterion, the participant will not be eligible. If the repeat assessment is not exclusionary, the participant will be eligible.
Has postural orthostatic tachycardia, defined as an increase of greater than (>) 30 beats per minute (bpm) or heart rate (HR) >120 bpm at approximately 3 minutes, of standing, at screening to predose assessments, inclusive. Any assessments after screening that do not meet this criterion may be repeated with the participant remaining standing for up to a total of 5 minutes, provided that the participant remains asymptomatic. If the repeat assessment occurring within 5 minutes is exclusionary based on the above criterion, the participant will not be eligible. A confirmed orthostatic increase of >30 bpm, but less than (<) 40 bpm, on 1 or more Day -1 assessments may not be considered exclusionary if not considered clinically significant by the investigator and the medical monitor. Such assessments must be discussed with the medical monitor prior to determination that the participant is eligible to proceed.
Has a known or suspected current coronavirus disease 2019 (COVID-19) infection or is at risk of COVID-19 infection as assessed by the investigator.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

PPD Development, LP
Austin, Texas, 78744
PPD Development, LP
Las Vegas, Nevada, 89113

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-510 in Healthy Subjects

This is a study of TAK-510 for people with symptoms of feeling sick (nausea) or being sick (vomiting).

The main aims of the study are to check if healthy adults have side effects from TAK-510 and to check how much TAK-510 they can receive without getting side effects from it.

The study will be in 3 parts. Participants will take part in only 1 of the 3 parts of the study.

At the first visit, the study doctor will check if each person can take part. For those who can take part, they will be placed in 1 of many small groups. The 1st groups will join Part 1 of the study, the 2nd groups will join Part 2 and the 3rd groups will join Part 3. They will receive an injection under the skin of either TAK-510 or placebo. In this study, a placebo will look like the TAK-510 injection but will not have any medicine in it.

In Part 1, the 1st group of participants will receive 1 injection of either TAK-510 or placebo. Different participants within this group will receive lower to higher doses of TAK-510. The participants in this group will stay in the clinic for 4 days after their injection for some tests and check for any side effects from their treatment.

In Part 2, the 2nd group of participants will receive an injection of either TAK-510 or placebo, once a day for 5 days. Different participants within this group will receive lower to higher doses of TAK-510. The participants in this group will stay in the clinic for 9 days after their 1st injection for some tests and check for any side effects from their treatment.

In Part 3, the 3rd group of participants will visit the clinic 2 times. At the 1st visit, they will receive an injection either of TAK-510 or placebo, once a day for 7 days. Each participant in this group will receive lower to higher doses of TAK-510. They will stay in the clinic for 8 days after their 1st injection for some tests and check for any side effects from their treatment.

At the 2nd clinic visit, each participant will receive 1 single injection of TAK-510 or placebo. This will happen 7 days after their last injection from the previous clinic visit. They will receive the same dose as their previous dose. They will stay in the clinic for 3 days for some tests and check for any side effects from their treatment.

After treatment, all participants in the study will return to the clinic for a weekly check-up visit for up to 3 weeks.

Read the detailed description

The drug being tested in this study is called TAK-510. The study will look at the safety, tolerability, and PK of TAK-510 in healthy participants.

The study will enroll up to approximately 224 healthy participants. Participants in each cohort will be randomized to receive treatment with TAK-510 or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). The study consists of 3 parts and up to 28 cohorts as mentioned below.

TAK-510, Part 1: Single rising dose (SRD) design to assess the safety, immunogenicity, tolerability, and PK of TAK-510
TAK-510, Part 2: Multiple rising dose (MRD) design to assess the safety, immunogenicity, tolerability, and PK of TAK-510
TAK-510, Part 3: Dose titration and redosing design to assess the safety, immunogenicity, tolerability, and PK of TAK-510

This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 57 days. Participants will be followed up for 7 days after the last dose of study drug for a follow-up assessment.

Conditions: Healthy Participants
Being tested: TAK-510, TAK-510 Placebo
Keywords: Drug Therapy

What participants receive

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

TAK-510Drug
TAK-510 solution.
TAK-510 PlaceboDrug
TAK-510 placebo-matching solution.

Study groups in NCT04731922
Study group	Role	What they receive
TAK-510: Part 1	Experimental	TAK-510 at starting dose of 5 microgram (mcg) or placebo-matching solution, subcutaneously, once on Day 1. Staggered dosing will be done in the first cohort of Part A (Cohort 1). Staggered dosing in subsequent Cohorts (Cohorts 2-12 and 21-25) will be used based on emerging safety, tolerability, and PK data from Cohort 1 as determined in the dose escalation meeting. Receives: Drug: TAK-510; Drug: TAK-510 Placebo
TAK-510: Part 2	Experimental	TAK-510 to be decided (TBD) or placebo-matching solution, subcutaneously, once daily from Day 1 through Day 5. Dose of MRD Cohorts (Cohorts 13-17 and 26-28) of Part 2 will be determined based on emerging safety, tolerability, and available PK data from Part 1 (SRD) and any available PK data from Part 2 as determined in the dose escalation meeting. Receives: Drug: TAK-510; Drug: TAK-510 Placebo
TAK-510: Part 3	Experimental	TAK-510 TBD or placebo-matching solution, subcutaneously, once daily from Days 1 to 7. Dose of dose titration and redosing Cohorts (Cohorts 18-20) of Part 3 will be based on emerging safety, tolerability, and available PK data from Part 1 (SRD) and Part 2 (MRD) as determined in the dose escalation meeting. Single redosing will be performed on Day 14 after 7 days of washout period following the 7 days treatment period. Receives: Drug: TAK-510; Drug: TAK-510 Placebo

What is being measured

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

Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Vital signs included systolic and diastolic blood pressure, body temperature, pulse rate (PR), respiratory rate, orthostatic blood pressure and pulse rate assessments. The markedly abnormal value (MAV) criteria for vital signs were systolic blood pressure (SBP) less than (<) 85 millimeter of mercury (mmHg), greater than (>) 180 mmHg; diastolic blood pressure (DBP) <50 mmHg, >110 mmHg; body temperature <35.6 degree Celsius, >37.7 degree Celsius; PR <50 beats per minute (bpm), >120 bpm; respiratory rate <12 breaths per minute (breaths/minute), >16 breaths/minute; orthostatic hypotension decrease in SBP greater than or equal to (>=) 20 mmHg or a decrease in DBP >=10 mmHg on standing; orthostatic tachycardia defined as an increase of >30 bpm or heart rate (HR) >120 bpm on standing. Number of participants who met the MAV criteria for vital signs at least once post dose were reported.
Measured: Parts 1 and 2: From the first dose of study drug up to Day 29
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose
ECG included HR, PR, QT interval with Fridericia correction (QTcF) interval and QRS duration. The MAV criteria for 12-lead ECG parameters included heart rate <50 bpm, >120 bpm; PR interval less than or equal to (<=)80 milliseconds (msec), >=200 msec; QTcF interval >=500 msec; QRS duration <=80 msec, >=120 msec. Number of participants who met the MAV criteria for ECG parameters at least once post dose were reported.
Measured: Parts 1 and 2: From the first dose of study drug up to Day 29
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose
Clinical laboratory parameters included tests for chemistry and hematology. The MAV criteria for laboratory value included hemoglobin <0.8*LLN,>1.2*ULN; hematocrit <0.8*LLN,>1.2*ULN;RBC count <0.8*LLN, >1.2*ULN;WBC count <0.5*LLN, >1.5*ULN; platelet count <75*10^9 per liter, >600*10^9 per liter; ALT >3*ULN; AST >3*ULN,GGT >3*ULN, normal baseline; >2*baseline,abnormal baseline; ALP>3*ULN, normal baseline; >2*baseline, abnormal baseline; total bilirubin >1.5*ULN, normal baseline; >1.5* baseline, abnormal baseline; albumin <25g/L; total protein <0.8* LLN, >1.2*ULN; creatinine >177 micromole per liter; blood urea nitrogen >10.7 mmol/L; sodium <130 mmol/L, >150mmol/L; potassium <3.0mmol/L, >5.5 mmol/L; glucose <3mmol/L, >10mmol/L; chloride <75mmol/L, >126mmol/L; calcium corrected serum calcium of <LLN-8.0 mg/dL; <LLN-2.0mmol/L; ionized calcium <LLN-1.0mmol/L; bicarbonate <8.0mmol/L. Number of participants who met the MAV criteria for laboratory value at least once post dose were reported.
Measured: Parts 1 and 2: From the first dose of study drug up to Day 29
Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)
A TEAE was defined as an adverse event (AE) that started or worsened after first dose of the study treatment and within 30 days of last dose of study treatment. An AE was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it did not necessarily had to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it was considered related to the drug.
Measured: From the first dose of study drug until 30 days after last dose in Parts 1 and 2 (SRD Cohorts: up to Day 31, MRD Cohorts: up to Day 35)

Secondary outcomes (8)

Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
Vital signs included systolic and diastolic blood pressure, body temperature, PR, respiratory rate, orthostatic blood pressure and pulse rate assessments. The MAV criteria for vital signs were systolic SBP < 85 mmHg, >180 mmHg; DBP <50 mmHg, >110 mmHg; body temperature <35.6 degree Celsius, >37.7 degree Celsius; PR <50 bpm, >120 bpm; respiratory rate <12 breaths/minute, >16 breaths/minute; orthostatic hypotension decrease in SBP >=20 mmHg or a decrease in DBP >=10 mmHg on standing; orthostatic tachycardia defined as an increase of >30 bpm or HR >120 bpm on standing. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.
Measured: Part 3: From the first dose of study drug up to Day 29
Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for ECG Parameters at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
ECG included HR, PR, QT QTcF interval and QRS duration. The MAV criteria for 12-lead ECG parameters included heart rate <50 bpm, >120 bpm; PR interval <=80 msec, >=200 msec; QTcF interval >=500 msec or >=30 msec change from baseline and >=450 msec; QRS duration <=80 msec, >=120 msec. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.
Measured: Part 3: From the first dose of study drug up to Day 29
Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
MAV criteria: hemoglobin <0.8*LLN,>1.2*ULN; hematocrit <0.8*LLN,>1.2*ULN;RBC count <0.8*LLN, >1.2*ULN;WBC count <0.5*LLN, >1.5*ULN; platelet count <75*10^9 per liter, >600*10^9 per liter; ALT >3*ULN; AST >3*ULN,GGT >3*ULN, normal baseline; >2*baseline,abnormal baseline; ALP>3*ULN, normal baseline; >2*baseline, abnormal baseline; total bilirubin >1.5*ULN, normal baseline; >1.5* baseline, abnormal baseline; albumin <25g/L; total protein <0.8* LLN, >1.2*ULN; creatinine >177 micromole per liter; blood urea nitrogen >10.7 mmol/L; sodium <130 mmol/L, >150mmol/L; potassium <3.0mmol/L, >5.5 mmol/L; glucose <3mmol/L, >10mmol/L; chloride <75mmol/L, >126mmol/L; calcium corrected serum calcium of <LLN-8.0 mg/dL; <LLN-2.0mmol/L; ionized calcium <LLN-1.0mmol/L; bicarbonate <8.0mmol/L. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3. Hence, no data collection and assessment were done in Part 3.
Measured: Part 3: From the first dose of study drug up to Day 29
Part 3, Number of Participants Reporting One or More TEAE Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
A TEAE was defined as an AE that started or worsened after first dose of the study treatment and within 30 days of last dose of study treatment. An AE was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it did not necessarily had to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it was considered related to the drug. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.
Measured: Part 3: From the first dose of study drug until 30 days after last dose (up to Day 37)
Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum
A 3-tiered ADA testing strategy was used in this study. A sample was initially screened for ADA by the ADA screening assay. Any positive sample in the screening assay was considered a potential positive, which was confirmed for true positivity by the confirmatory assay. If a sample was confirmed as an ADA true positive, ADA titer was assessed. ADA positive was defined as participants who had confirmed positive ADA status in at least 1 postbaseline assessments. ADA negative was defined as participants who did not have a confirmed negative ADA status in any post-baseline assessment.
Measured: Parts 1 and 2: From the first dose of study drug up to Day 29
Part 3: Number of Participants Based on ADA Status (Positive and Negative) in Serum
A 3-tiered ADA testing strategy was used in this study. A sample was initially screened for ADA by the ADA screening assay. Any positive sample in the screening assay was considered a potential positive, which was confirmed for true positivity by the confirmatory assay. If a sample was confirmed as an ADA true positive, ADA titer was assessed. ADA positive was defined as participants who had confirmed positive ADA status in at least 1 postbaseline assessments. ADA negative was defined as participants who did not have a confirmed negative ADA status in any post-baseline assessment. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.
Measured: Part 3: From the first dose of study drug up to Day 29
Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer
The high ADA titer was defined as participant who has at least 1 post-baseline ADA titer >16 and low ADA titer was defined as participant whose postbaseline ADA titers are all <=16. The low or high ADA titer was assessed in ADA positive participants only.
Measured: Parts 1 and 2: From the first dose of study drug up to Day 29
Part 3: Number of ADA Positive Participants Based on Low or High ADA Titer
The high ADA titer was defined as participant who has at least 1 post-baseline ADA titer >16 and low ADA titer was defined as participant whose postbaseline ADA titers are all <=16. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.
Measured: Part 3: From the first dose of study drug up to Day 29

Timeline

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

3 Feb 202124 Jul 2022

First posted1 Feb 2021
Study start3 Feb 2021
Primary completion24 Jul 2022
Study completion24 Jul 2022

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 ParticipantsStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04731922
Sponsor's protocol ID: TAK-510-1001
Other IDs: U1111-1261-6974
Status last verified: Jul 2023
First submitted: 27 Jan 2021
Last updated: 4 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-510 in Healthy Subjects
ClinicalTrials.gov ID: NCT04731922
Acronym / sponsor ID: TAK-510-1001
Conditions: Healthy Participants
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 3 Feb 2021 (actual)
Primary completion: 24 Jul 2022 (actual)
Study completion: 24 Jul 2022 (actual)
First posted: 1 Feb 2021 (actual)
Results: Posted 4 Mar 2024

Clinical summary

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

This is a study of TAK-510 for people with symptoms of feeling sick (nausea) or being sick (vomiting).

The main aims of the study are to check if healthy adults have side effects from TAK-510 and to check how much TAK-510 they can receive without getting side effects from it.

The study will be in 3 parts. Participants will take part in only 1 of the 3 parts of the study.

After treatment, all participants in the study will return to the clinic for a weekly check-up visit for up to 3 weeks.

Detailed description

The drug being tested in this study is called TAK-510. The study will look at the safety, tolerability, and PK of TAK-510 in healthy participants.

TAK-510, Part 1: Single rising dose (SRD) design to assess the safety, immunogenicity, tolerability, and PK of TAK-510
TAK-510, Part 2: Multiple rising dose (MRD) design to assess the safety, immunogenicity, tolerability, and PK of TAK-510
TAK-510, Part 3: Dose titration and redosing design to assess the safety, immunogenicity, tolerability, and PK of TAK-510

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
TAK-510: Part 1	Experimental	Drug: TAK-510, Drug: TAK-510 PlaceboTAK-510 at starting dose of 5 microgram (mcg) or placebo-matching solution, subcutaneously, once on Day 1. Staggered dosing will be done in the first cohort of Part A (Cohort 1). Staggered dosing in subsequent Cohorts (Cohorts 2-12 and 21-25) will be used based on emerging safety, tolerability, and PK data from Cohort 1 as determined in the dose escalation meeting.
TAK-510: Part 2	Experimental	Drug: TAK-510, Drug: TAK-510 PlaceboTAK-510 to be decided (TBD) or placebo-matching solution, subcutaneously, once daily from Day 1 through Day 5. Dose of MRD Cohorts (Cohorts 13-17 and 26-28) of Part 2 will be determined based on emerging safety, tolerability, and available PK data from Part 1 (SRD) and any available PK data from Part 2 as determined in the dose escalation meeting.
TAK-510: Part 3	Experimental	Drug: TAK-510, Drug: TAK-510 PlaceboTAK-510 TBD or placebo-matching solution, subcutaneously, once daily from Days 1 to 7. Dose of dose titration and redosing Cohorts (Cohorts 18-20) of Part 3 will be based on emerging safety, tolerability, and available PK data from Part 1 (SRD) and Part 2 (MRD) as determined in the dose escalation meeting. Single redosing will be performed on Day 14 after 7 days of washout period following the 7 days treatment period.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing and throughout the study.
Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2) at the screening visit.

Key exclusion criteria (9 listed)

Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody/antigen, at the screening visit.
Had major surgery or donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the screening visit.
Unable to refrain from or anticipates using all medications including herbal medicines beginning approximately 7 days before administration of the first dose of study drug, throughout the study until 2 days after discharge.
Unable to refrain from or anticipates using marijuana or cannabis-containing products beginning approximately 7 days before administration of the first dose of study drug, throughout the study until after the last PK dose.
Has had a previous major psychotic disorder.

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
TAK-510TAK-510 solution.	Drug	TAK-510: Part 1, TAK-510: Part 2, TAK-510: Part 3
TAK-510 PlaceboTAK-510 placebo-matching solution.	Drug	TAK-510: Part 1, TAK-510: Part 2, TAK-510: Part 3

Primary outcome

Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29
Vital signs included systolic and diastolic blood pressure, body temperature, pulse rate (PR), respiratory rate, orthostatic blood pressure and pulse rate assessments. The markedly abnormal value (MAV) criteria for vital signs were systolic blood pressure (SBP) less than (<) 85 millimeter of mercury (mmHg), greater than (>) 180 mmHg; diastolic blood pressure (DBP) <50 mmHg, >110 mmHg; body temperature <35.6 degree Celsius, >37.7 degree Celsius; PR <50 beats per minute (bpm), >120 bpm; respiratory rate <12 breaths per minute (breaths/minute), >16 breaths/minute; orthostatic hypotension decrease in SBP greater than or equal to (>=) 20 mmHg or a decrease in DBP >=10 mmHg on standing; orthostatic tachycardia defined as an increase of >30 bpm or heart rate (HR) >120 bpm on standing. Number of participants who met the MAV criteria for vital signs at least once post dose were reported.
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose
Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29
ECG included HR, PR, QT interval with Fridericia correction (QTcF) interval and QRS duration. The MAV criteria for 12-lead ECG parameters included heart rate <50 bpm, >120 bpm; PR interval less than or equal to (<=)80 milliseconds (msec), >=200 msec; QTcF interval >=500 msec; QRS duration <=80 msec, >=120 msec. Number of participants who met the MAV criteria for ECG parameters at least once post dose were reported.
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose
Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29
Clinical laboratory parameters included tests for chemistry and hematology. The MAV criteria for laboratory value included hemoglobin <0.8*LLN,>1.2*ULN; hematocrit <0.8*LLN,>1.2*ULN;RBC count <0.8*LLN, >1.2*ULN;WBC count <0.5*LLN, >1.5*ULN; platelet count <75*10^9 per liter, >600*10^9 per liter; ALT >3*ULN; AST >3*ULN,GGT >3*ULN, normal baseline; >2*baseline,abnormal baseline; ALP>3*ULN, normal baseline; >2*baseline, abnormal baseline; total bilirubin >1.5*ULN, normal baseline; >1.5* baseline, abnormal baseline; albumin <25g/L; total protein <0.8* LLN, >1.2*ULN; creatinine >177 micromole per liter; blood urea nitrogen >10.7 mmol/L; sodium <130 mmol/L, >150mmol/L; potassium <3.0mmol/L, >5.5 mmol/L; glucose <3mmol/L, >10mmol/L; chloride <75mmol/L, >126mmol/L; calcium corrected serum calcium of <LLN-8.0 mg/dL; <LLN-2.0mmol/L; ionized calcium <LLN-1.0mmol/L; bicarbonate <8.0mmol/L. Number of participants who met the MAV criteria for laboratory value at least once post dose were reported.
Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)
Time frame: From the first dose of study drug until 30 days after last dose in Parts 1 and 2 (SRD Cohorts: up to Day 31, MRD Cohorts: up to Day 35)
A TEAE was defined as an adverse event (AE) that started or worsened after first dose of the study treatment and within 30 days of last dose of study treatment. An AE was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it did not necessarily had to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it was considered related to the drug.

8 secondary outcomes

Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
Time frame: Part 3: From the first dose of study drug up to Day 29
Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for ECG Parameters at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
Time frame: Part 3: From the first dose of study drug up to Day 29
Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
Time frame: Part 3: From the first dose of study drug up to Day 29
Part 3, Number of Participants Reporting One or More TEAE Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
Time frame: Part 3: From the first dose of study drug until 30 days after last dose (up to Day 37)
Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum
Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29
Part 3: Number of Participants Based on ADA Status (Positive and Negative) in Serum
Time frame: Part 3: From the first dose of study drug up to Day 29
Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer
Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29
Part 3: Number of ADA Positive Participants Based on Low or High ADA Titer
Time frame: Part 3: From the first dose of study drug up to Day 29

Results and safety

Results posted to the registry on 4 Mar 2024, 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 1, SRD Cohorts 1 to 11: Pooled Placebo	23	22
Part 1, SRD Cohort 1: TAK-510 Dose 1	6	6
Part 1, SRD Cohort 2: TAK-510 Dose 2	6	6
Part 1, SRD Cohort 3: TAK-510 Dose 3	6	5
Part 1, SRD Cohort 4: TAK-510 Dose 4	7	6
Part 1, SRD Cohort 5: TAK-510 Dose 5	6	5
Part 1, SRD Cohort 6: TAK-510 Dose 6	6	4
Part 1, SRD Cohort 7: TAK-510 Dose 7	6	6
Part 1, SRD Cohort 8: TAK-510 Dose 8	6	6
Part 1, SRD Cohort 9: TAK-510 Dose 9	6	6
Part 1, SRD Cohort 10: TAK-510 Dose 10	6	5
Part 1, SRD Cohort 11: TAK-510 Dose 11	6	6
Part 2, MRD 12 to 15 Cohorts: Pooled Placebo	8	8
Part 2, MRD Cohort 12: Dose 1A	8	7
Part 2, MRD Cohort 13: Dose 2A	6	6
Part 2, MRD Cohort 14: Dose 3A	6	6
Part 2, MRD Cohort 15: Dose 4A	6	6

Primary outcome: Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose

Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29. Count of participants. Unit: Participants

Measure	Part 1, SRD Cohort 3: TAK-510 Dose 3 n = 6	Part 1, SRD Cohort 4: TAK-510 Dose 4 n = 7	Part 1, SRD Cohort 5: TAK-510 Dose 5 n = 6	Part 1, SRD Cohort 6: TAK-510 Dose 6 n = 6	Part 1, SRD Cohort 7: TAK-510 Dose 7 n = 6	Part 1, SRD Cohort 8: TAK-510 Dose 8 n = 6	Part 1, SRD Cohort 9: TAK-510 Dose 9 n = 6	Part 1, SRD Cohort 10: TAK-510 Dose 10 n = 6	Part 1, SRD Cohort 11: TAK-510 Dose 11 n = 6	Part 2, MRD 12 to 15 Cohorts: Pooled Placebo n = 8	Part 2, MRD Cohort 12: Dose 1A n = 8	Part 2, MRD Cohort 13: Dose 2A n = 6	Part 2, MRD Cohort 14: Dose 3A n = 6	Part 2, MRD Cohort 15: Dose 4A n = 6
Temperature, <35.6 Degree Celsius	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Temperature, >37.7 Degree Celsius	0	0	0	0	0	0	0	0	0	0	0	0	0	0
SBP, Standing: <85 mmHg	0	0	1	0	0	0	0	0	1	0	0	0	0	2
SBP, Standing: >180 mmHg	0	0	0	0	0	0	0	0	0	0	0	0	0	0
DBP, Standing: <50 mmHg	0	0	1	0	1	0	0	0	1	0	1	0	0	3
DBP, Standing: >110 mmHg	0	0	0	0	0	0	0	0	0	0	0	0	0	0
PR, Standing: <50 bpm	0	0	0	0	0	0	0	0	0	0	0	0	0	0
PR, Standing: >120 bpm	1	2	4	2	2	5	4	5	2	1	4	1	4	4

Population analysed: The safety analysis set included all participants who were randomized and received at least 1 dose of study treatment.

Primary outcome: Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose

Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29. Count of participants. Unit: Participants

Measure	Part 1, SRD Cohorts 1 to 11: Pooled Placebo n = 23	Part 1, SRD Cohort 4: TAK-510 Dose 4 n = 7	Part 1, SRD Cohort 5: TAK-510 Dose 5 n = 6	Part 1, SRD Cohort 6: TAK-510 Dose 6 n = 6	Part 1, SRD Cohort 7: TAK-510 Dose 7 n = 6	Part 1, SRD Cohort 8: TAK-510 Dose 8 n = 6	Part 1, SRD Cohort 9: TAK-510 Dose 9 n = 6	Part 1, SRD Cohort 10: TAK-510 Dose 10 n = 6	Part 1, SRD Cohort 11: TAK-510 Dose 11 n = 6	Part 2, MRD 12 to 15 Cohorts: Pooled Placebo n = 8	Part 2, MRD Cohort 12: Dose 1A n = 8	Part 2, MRD Cohort 13: Dose 2A n = 6	Part 2, MRD Cohort 14: Dose 3A n = 6	Part 2, MRD Cohort 15: Dose 4A n = 6
ECG HR, <50 bpm	1	0	0	0	0	0	0	0	0	0	0	0	0	0
ECG HR, >120 bpm	0	2	0	0	0	1	0	3	0	0	0	0	1	1
PR Interval, <=80 msec	0

Primary outcome: Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose

Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29. Count of participants. Unit: Participants

Measure	Part 1, SRD Cohorts 1 to 11: Pooled Placebo n = 23	Part 1, SRD Cohort 1: TAK-510 Dose 1 n = 6	Part 1, SRD Cohort 2: TAK-510 Dose 2 n = 6	Part 1, SRD Cohort 3: TAK-510 Dose 3 n = 7	Part 1, SRD Cohort 4: TAK-510 Dose 4 n = 6	Part 1, SRD Cohort 5: TAK-510 Dose 5 n = 6	Part 1, SRD Cohort 6: TAK-510 Dose 6 n = 6	Part 1, SRD Cohort 7: TAK-510 Dose 7 n = 6	Part 1, SRD Cohort 8: TAK-510 Dose 8 n = 6	Part 1, SRD Cohort 9: TAK-510 Dose 9 n = 6	Part 1, SRD Cohort 10: TAK-510 Dose 10 n = 6	Part 1, SRD Cohort 11: TAK-510 Dose 11 n = 6	Part 2, MRD 12 to 15 Cohorts: Pooled Placebo n = 8	Part 2, MRD Cohort 12: Dose 1A n = 8	Part 2, MRD Cohort 13: Dose 2A n = 6	Part 2, MRD Cohort 14: Dose 3A n = 6	Part 2, MRD Cohort 15: Dose 4A n = 6
Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN)	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0

Population analysed: The safety analysis set included all participants who were randomized and received at least 1 dose of study treatment. Here, LLN = lower limit of normal; RBC = red blood cell; WBC = white blood cell; ALP = alkaline phosphatase; GGT = Gamma-glutamyl transferase; g/L = gram per liter; mmol/L = millimoles per liter; mg/dL = milligrams per deciliter.

Primary outcome: Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)

Time frame: From the first dose of study drug until 30 days after last dose in Parts 1 and 2 (SRD Cohorts: up to Day 31, MRD Cohorts: up to Day 35). Count of participants. Unit: Participants

Measure	Part 1, SRD Cohorts 1 to 11: Pooled Placebo n = 23	Part 1, SRD Cohort 1: TAK-510 Dose 1 n = 6	Part 1, SRD Cohort 2: TAK-510 Dose 2 n = 6	Part 1, SRD Cohort 3: TAK-510 Dose 3 n = 6	Part 1, SRD Cohort 4: TAK-510 Dose 4 n = 7	Part 1, SRD Cohort 5: TAK-510 Dose 5 n = 6	Part 1, SRD Cohort 6: TAK-510 Dose 6 n = 6	Part 1, SRD Cohort 7: TAK-510 Dose 7 n = 6	Part 1, SRD Cohort 8: TAK-510 Dose 8 n = 6	Part 1, SRD Cohort 9: TAK-510 Dose 9 n = 6	Part 1, SRD Cohort 10: TAK-510 Dose 10 n = 6	Part 1, SRD Cohort 11: TAK-510 Dose 11 n = 6	Part 2, MRD 12 to 15 Cohorts: Pooled Placebo n = 8	Part 2, MRD Cohort 12: Dose 1A n = 8	Part 2, MRD Cohort 13: Dose 2A n = 6	Part 2, MRD Cohort 14: Dose 3A n = 6	Part 2, MRD Cohort 15: Dose 4A n = 6
Value	10	1	3	3	4	6	6	4	6	4	6	6	5	7	3	6	5

Population analysed: The safety analysis set included all participants who were randomized and received at least 1 dose of study treatment.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: TEAEs are AEs that started after the first dose of study drug until 30 days after last dose in Parts 1 and 2 (SRD Cohorts: up to Day 31, MRD Cohorts: up to Day 35). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1, SRD Cohorts 1 to 11: Pooled Placebo	0 of 23 (0%)	9 of 23 (39.1%)	0 of 23
Part 1, SRD Cohort 1: TAK-510 Dose 1	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part 1, SRD Cohort 2: TAK-510 Dose 2	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 1, SRD Cohort 3: TAK-510 Dose 3	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 1, SRD Cohort 4: TAK-510 Dose 4	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7
Part 1, SRD Cohort 5: TAK-510 Dose 5	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part 1, SRD Cohort 6: TAK-510 Dose 6	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part 1, SRD Cohort 7: TAK-510 Dose 7	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part 1, SRD Cohort 8: TAK-510 Dose 8	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part 1, SRD Cohort 9: TAK-510 Dose 9	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part 1, SRD Cohort 10: TAK-510 Dose 10	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part 1, SRD Cohort 11: TAK-510 Dose 11	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part 2, MRD 12 to 15 Cohorts: Pooled Placebo	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Part 2, MRD Cohort: Dose 1A	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
Part 2, MRD Cohort 13: Dose 2A	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 2, MRD Cohort 14: Dose 3A	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part 2, MRD Cohort 15: Dose 4A	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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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.

Study Director study director

Takeda

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-510 in people with Healthy Participants, run by Takeda at 2 sites in United States.

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 2 inclusion and 9 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 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 4 Mar 2024). 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?

Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose (time frame: Parts 1 and 2: From the first dose of study drug up to Day 29). The study lists 4 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 NCT04731922.

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 4 Mar 2024.