Ulcerative ColitisPhase 1NCT06627556
A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants
A Phase 1 study testing H021 in people with Ulcerative Colitis, run by Jiangsu Carephar Pharmaceutical Co., Ltd. at 1 site in Australia.
Trial summary
The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- H021
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Sep 2024to 27 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), greater than and equal to (>=) 18 and less than and equal to (<=) 55 years of age, with body mass index (BMI) greater than (>)18.5 and less than (<) 32.0 kilograms per square meter (kg/m^2).
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
- the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- Female participants of non-childbearing potential must be:
- post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented follicle-stimulating hormone (FSH) levels >=40 milli-international units per milliliter (mIU/mL); or
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- surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or bilateral tubal occlusion) at least 3 months prior to dosing.
- Participants must be willing not to donate sperm for 90 days or ova (egg) for 6 months after the last dose.
- Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
- Able to understand the study procedures and provide signed informed consent to participate in the study.
Who cannot join
- Any clinically significant abnormal finding at physical examination.
- Clinically significant abnormal laboratory test results including biochemistry, hematology, urinalysis, and coagulation results, or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, or QuantiFERON®-TB test at screening.
- Positive pregnancy test or lactating female participant.
- Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -1.
- History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
- Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood pressure lower than 90 or over 140 millimetres of mercury (mmHg), diastolic blood pressure lower than 40 or over 90 mmHg, heart rate less than 40 or over 100 beats per minute (bpm), respiratory rate less than 10 or over 22 bpm), or oxygen saturation less than 95 percent (%) oxygen at screening.
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- History of drug abuse within 1 year prior to screening as determined by the investigator.
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 1 month prior to screening that exceeds 10 units of alcohol per week for women and men (1 unit = 375 [milliliter] mL of beer 3.5%, 100 mL of wine 13.5%, or 30 mL of distilled alcohol 40%).
- History of active tuberculosis or presence of active or latent tuberculosis. Previous latent tuberculosis that has been treated and is no longer active is not exclusionary.
- History of clinically significant opportunistic infection (example, invasive candidiasis or pneumocystis pneumonia).
- History of serious local infection (example, cellulitis, abscess) or systemic infection (example, septicemia) within 3 months prior to screening.
- Presence of fever (body temperature greater than (>) 37.5 degrees Celsius (°C) (example, a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.
- Use of medications within the timeframes specified.
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or simultaneous participation in an investigational study involving no drug or device administration.
- Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
- Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network Ply Ltd.
Melbourne, Victoria, 3004
Ofer Gonen, 0385939801, o.gonen@nucleusnetwork.com.au
Dr. Ofer Gonen
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of H021 in Healthy Participants
The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants.
Read the detailed description
This is a single center, Phase 1, randomized, double-blind, placebo controlled, sequential single ascending dose/multiple ascending dose (SAD/MAD) study, with a food-effect arm. The study will be divided into two parts:
- SAD cohorts, with food-effect evaluation
- MAD cohorts The two parts will be completed sequentially but with partial overlapping. The MAD phase can start once safety, tolerability, and pharmacokinetic data from the SAD phase show that single doses of at least 25 mg are acceptable. If the 25 mg dose will be not reached in the SAD phase, the Safety Review Committee (SRC) will set a new starting dose.
- Conditions
- Ulcerative Colitis
- Being tested
- H021, H021 Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H021Drug
H021 oral tablet.
H021 PlaceboDrug
H021 placebo oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1: H021 6.25 milligrams (mg) | Experimental | Participants will receive H021, 6.25 mg oral tablet, as single-dose on Day 1 under fasting or fed conditions. Receives: Drug: H021 |
| SAD Cohort 2: H021 12.5 mg | Experimental | Participants will receive H021, 12.5 mg oral tablet, as single-dose on Day 1 under fasting conditions. Receives: Drug: H021 |
| SAD Cohort 3: H021 25 mg | Experimental | Participants will receive H021, 25 mg oral tablet, as single-dose on Day 1 under fasting conditions. Receives: Drug: H021 |
| SAD Cohort 4: H021 50 mg | Experimental | Participants will receive H021, 50 mg oral tablet, as single-dose on Day 1 under fasting conditions. Receives: Drug: H021 |
| SAD Cohort 5: H021 100 mg | Experimental | Participants will receive H021, 100 mg oral tablet, as single-dose on Day 1 under fasting conditions. Receives: Drug: H021 |
| MAD Cohort 6: H021 12.5 mg | Experimental | Participants will receive H021, 12.5 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions. Receives: Drug: H021 |
| MAD Cohort 7: H021 25 mg | Experimental | Participants will receive H021, 25 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions. Receives: Drug: H021 |
| MAD Cohort 8: H021 50 mg | Experimental | Participants will receive H021, 50 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions. Receives: Drug: H021 |
| SAD-H021 Placebo | Placebo comparator | Participants will receive H021, placebo oral tablet, as single-dose on Day 1 under fasting or fed conditions. Receives: Drug: H021 Placebo |
| MAD-H021 Placebo | Placebo comparator | Participants will receive H021, placebo oral tablet once daily from Day 1 to Day 7 under fasting conditions. Receives: Drug: H021 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any clinically significant changes in vital signs, electrocardiogram (ECG) measurement, physical examination and clinical laboratory parameters will be recorded as AE.
Measured: Up to final follow-up (SAD Part: up to 8 days: MAD Part: up to 14 days)
Secondary outcomes (30)
SAD Part: Area under the concentration-time curve from time zero until the last observed concentration (AUC0-t) of H021
AUC0-t is an area under the concentration-time curve from time zero (pre-dose) to time of last observed concentration.
Measured: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Area under the concentration-time curve from time zero to infinity (AUC0-infinity) of H021
AUC0-infinity is an area under the concentration-time curve from time zero to infinity (extrapolated).
Measured: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Maximal observed concentration (Cmax) of H021
Cmax is a measure of the maximum amount of drug in the plasma after the dose was given.
Measured: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Time to Reach Cmax (Tmax) of H021
Tmax is a measure of the time to reach the maximum concentration in the plasma after the dose was given.
Measured: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Lag Time (Tlag) of H021
Tlag is time of observation prior to the first observation with a measurable (non-zero) concentration (for food effect cohort only).
Measured: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Residual area of H021
Residual area is calculated as percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as [1 - (AUC0-t/AUC0-inf)] x 100.
Measured: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24), and 48 hours post-dose
SAD Part: Terminal elimination half-life (T1/2 el) of H021
T1/2 el is defined as the duration until observation of half of the maximum concentration of drug dose.
Measured: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Terminal elimination rate constant (Kel) of H021
Kel is defined as first-order rate constant associated with the terminal (log-linear) portion of the curve.
Measured: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Apparent clearance (CL/F) of H021
CL/F is apparent total clearance of the drug from plasma after oral administration
Measured: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Apparent volume of distribution (Vz/F) of H021
Vz/F is apparent volume of distribution during terminal phase after non-intravenous administration
Measured: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t) of H021
Ae0-t is defined as cumulative urinary excretion from time zero to time t, calculated as the sum of the amounts excreted over each collection interval.
Measured: pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
SAD Part: Maximal Rate of Urinary Excretion (Rmax) of H021
Rmax is defined as maximal rate of urinary excretion, calculated by dividing the amount of drug excreted in each collection interval by the time over which it was collected.
Measured: pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
SAD Part: Time of Maximal Urinary Excretion (TRmax) of H021
TRmax is defined as time of maximal urinary excretion, calculated as the midpoint of the collection interval during which Rmax occurred.
Measured: pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
SAD Part: Renal Clearance (CLR) of H021
CLR is renal clearance, calculated as Ae0-t /AUC0-t.
Measured: pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
MAD Part: Area under the concentration-time curve from time zero to time 24 hours (AUC0-24) of H021
AUC0-24 is an area under the concentration-time curve from time zero to 24 hours post-dose.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Cmax of H021
Cmax is a measure of the maximum amount of drug in the plasma after the dose was given.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Tmax of H021
Tmax is a measure of the time to reach the maximum concentration in the plasma after the dose was given.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Area under the concentration-time curve for one dosing interval (τ) at steady- state (AUC0-τ) of H021
AUC0-τ is an area under the concentration-time curve for one dosing interval (τ) at steady- state. In this study τ = 24 hours (equivalent to AUC0-24) will be reported.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Cmax ss of H021
Cmax ss is a measure of the maximum amount of drug in the plasma at steady-state after the dose was given.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Tmax ss of H021
Tmax ss is a measure of the time to reach the maximum concentration in the plasma at steady state after the dose was given.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Minimal observed concentration at steady-state (Cmin ss) of H021
Cmin ss is minimal observed concentration at steady-state.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: AUC0-t of H021
AUC0-t is an area under the concentration-time curve from time zero (pre-dose) to time of last observed concentration.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: AUC0-inf of H021
AUC0-infinity is an area under the concentration-time curve from time zero to infinity (extrapolated).
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Residual area of H021
Residual area is calculated as percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as [1 - (AUC0-t/AUC0-inf)] x 100.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: T½ el of H021
T1/2 el is defined as the duration until observation of half of the maximum concentration of drug dose.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Kel of H021
Kel is defined as first-order rate constant associated with the terminal (log-linear) portion of the curve.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Apparent clearance at steady-state (Clss/F) of H021
Clss/F is apparent clearance at steady-state.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Apparent volume of distribution at steady-state (Vz ss/F) of H021
Vz ss/F is apparent volume of distribution at steady-state.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Accumulation ratio (RAUC)
RAUC is accumulation ratio for AUC.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Accumulation Ratio (RCmax)
RCmax is accumulation ratio for Cmax.
Measured: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start17 Sep 2024
- Primary completion27 Feb 2025 (estimated)
- Study completion27 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Carephar Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627556
- Sponsor's protocol ID
- KFP-2024-H021-HW-101
- Status last verified
- Sep 2024
- First submitted
- 3 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of H021 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06627556
- Acronym / sponsor ID
- KFP-2024-H021-HW-101
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Jiangsu Carephar Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 27 Feb 2025 (estimated)
- Study completion
- 27 Feb 2025 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants.
Detailed description
This is a single center, Phase 1, randomized, double-blind, placebo controlled, sequential single ascending dose/multiple ascending dose (SAD/MAD) study, with a food-effect arm. The study will be divided into two parts:
- SAD cohorts, with food-effect evaluation
- MAD cohorts The two parts will be completed sequentially but with partial overlapping. The MAD phase can start once safety, tolerability, and pharmacokinetic data from the SAD phase show that single doses of at least 25 mg are acceptable. If the 25 mg dose will be not reached in the SAD phase, the Safety Review Committee (SRC) will set a new starting dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1: H021 6.25 milligrams (mg) | Experimental | Drug: H021Participants will receive H021, 6.25 mg oral tablet, as single-dose on Day 1 under fasting or fed conditions. |
| SAD Cohort 2: H021 12.5 mg | Experimental | Drug: H021Participants will receive H021, 12.5 mg oral tablet, as single-dose on Day 1 under fasting conditions. |
| SAD Cohort 3: H021 25 mg | Experimental | Drug: H021Participants will receive H021, 25 mg oral tablet, as single-dose on Day 1 under fasting conditions. |
| SAD Cohort 4: H021 50 mg | Experimental | Drug: H021Participants will receive H021, 50 mg oral tablet, as single-dose on Day 1 under fasting conditions. |
| SAD Cohort 5: H021 100 mg | Experimental | Drug: H021Participants will receive H021, 100 mg oral tablet, as single-dose on Day 1 under fasting conditions. |
| MAD Cohort 6: H021 12.5 mg | Experimental | Drug: H021Participants will receive H021, 12.5 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions. |
| MAD Cohort 7: H021 25 mg | Experimental | Drug: H021Participants will receive H021, 25 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions. |
| MAD Cohort 8: H021 50 mg | Experimental | Drug: H021Participants will receive H021, 50 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions. |
| SAD-H021 Placebo | Placebo comparator | Drug: H021 PlaceboParticipants will receive H021, placebo oral tablet, as single-dose on Day 1 under fasting or fed conditions. |
| MAD-H021 Placebo | Placebo comparator | Drug: H021 PlaceboParticipants will receive H021, placebo oral tablet once daily from Day 1 to Day 7 under fasting conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), greater than and equal to (>=) 18 and less than and equal to (<=) 55 years of age, with body mass index (BMI) greater than (>)18.5 and less than (<) 32.0 kilograms per square meter (kg/m^2).
- Healthy as defined by:
- Female participants of non-childbearing potential must be:
- Participants must be willing not to donate sperm for 90 days or ova (egg) for 6 months after the last dose.
- Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
Key exclusion criteria (16 listed)
- Any clinically significant abnormal finding at physical examination.
- Clinically significant abnormal laboratory test results including biochemistry, hematology, urinalysis, and coagulation results, or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, or QuantiFERON®-TB test at screening.
- Positive pregnancy test or lactating female participant.
- Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -1.
- History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
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 |
|---|---|---|
| H021H021 oral tablet. | Drug | MAD Cohort 6: H021 12.5 mg, MAD Cohort 7: H021 25 mg, MAD Cohort 8: H021 50 mg, SAD Cohort 1: H021 6.25 milligrams (mg), SAD Cohort 2: H021 12.5 mg, SAD Cohort 3: H021 25 mg, SAD Cohort 4: H021 50 mg, SAD Cohort 5: H021 100 mg |
| H021 PlaceboH021 placebo oral tablet. | Drug | MAD-H021 Placebo, SAD-H021 Placebo |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to final follow-up (SAD Part: up to 8 days: MAD Part: up to 14 days)
An AE is defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any clinically significant changes in vital signs, electrocardiogram (ECG) measurement, physical examination and clinical laboratory parameters will be recorded as AE.
30 secondary outcomes
SAD Part: Area under the concentration-time curve from time zero until the last observed concentration (AUC0-t) of H021
Time frame: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Area under the concentration-time curve from time zero to infinity (AUC0-infinity) of H021
Time frame: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Maximal observed concentration (Cmax) of H021
Time frame: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Time to Reach Cmax (Tmax) of H021
Time frame: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Lag Time (Tlag) of H021
Time frame: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Residual area of H021
Time frame: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24), and 48 hours post-dose
SAD Part: Terminal elimination half-life (T1/2 el) of H021
Time frame: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Terminal elimination rate constant (Kel) of H021
Time frame: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Apparent clearance (CL/F) of H021
Time frame: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Apparent volume of distribution (Vz/F) of H021
Time frame: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
SAD Part: Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t) of H021
Time frame: pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
SAD Part: Maximal Rate of Urinary Excretion (Rmax) of H021
Time frame: pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
SAD Part: Time of Maximal Urinary Excretion (TRmax) of H021
Time frame: pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
SAD Part: Renal Clearance (CLR) of H021
Time frame: pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
MAD Part: Area under the concentration-time curve from time zero to time 24 hours (AUC0-24) of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Cmax of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Tmax of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Area under the concentration-time curve for one dosing interval (τ) at steady- state (AUC0-τ) of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Cmax ss of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Tmax ss of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Minimal observed concentration at steady-state (Cmin ss) of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: AUC0-t of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: AUC0-inf of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Residual area of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: T½ el of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Kel of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Apparent clearance at steady-state (Clss/F) of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Apparent volume of distribution at steady-state (Vz ss/F) of H021
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Accumulation ratio (RAUC)
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
MAD Part: Accumulation Ratio (RCmax)
Time frame: Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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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.
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 H021 in people with Ulcerative Colitis, run by Jiangsu Carephar Pharmaceutical Co., Ltd. at 1 site in Australia.
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 10 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 4 Oct 2024. 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Ofer Gonen (0385939801, o.gonen@nucleusnetwork.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Up to final follow-up (SAD Part: up to 8 days: MAD Part: up to 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2024.