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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06627556




Registration number
NCT06627556
Ethics application status
Date submitted
3/10/2024
Date registered
4/10/2024

Titles & IDs
Public title
A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants
Scientific 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
Secondary ID [1] 0 0
KFP-2024-H021-HW-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - H021
Treatment: Drugs - H021 Placebo

Experimental: SAD Cohort 1: H021 6.25 milligrams (mg) - Participants will receive H021, 6.25 mg oral tablet, as single-dose on Day 1 under fasting or fed conditions.

Experimental: SAD Cohort 2: H021 12.5 mg - Participants will receive H021, 12.5 mg oral tablet, as single-dose on Day 1 under fasting conditions.

Experimental: SAD Cohort 3: H021 25 mg - Participants will receive H021, 25 mg oral tablet, as single-dose on Day 1 under fasting conditions.

Experimental: SAD Cohort 4: H021 50 mg - Participants will receive H021, 50 mg oral tablet, as single-dose on Day 1 under fasting conditions.

Experimental: SAD Cohort 5: H021 100 mg - Participants will receive H021, 100 mg oral tablet, as single-dose on Day 1 under fasting conditions.

Experimental: MAD Cohort 6: H021 12.5 mg - Participants will receive H021, 12.5 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions.

Experimental: MAD Cohort 7: H021 25 mg - Participants will receive H021, 25 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions.

Experimental: MAD Cohort 8: H021 50 mg - Participants will receive H021, 50 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions.

Placebo comparator: SAD-H021 Placebo - Participants will receive H021, placebo oral tablet, as single-dose on Day 1 under fasting or fed conditions.

Placebo comparator: MAD-H021 Placebo - Participants will receive H021, placebo oral tablet once daily from Day 1 to Day 7 under fasting conditions.


Treatment: Drugs: H021
H021 oral tablet.

Treatment: Drugs: H021 Placebo
H021 placebo oral tablet.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to final follow-up (SAD Part: up to 8 days: MAD Part: up to 14 days)
Secondary outcome [1] 0 0
SAD Part: Area under the concentration-time curve from time zero until the last observed concentration (AUC0-t) of H021
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
SAD Part: Area under the concentration-time curve from time zero to infinity (AUC0-infinity) of H021
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
SAD Part: Maximal observed concentration (Cmax) of H021
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
SAD Part: Time to Reach Cmax (Tmax) of H021
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
SAD Part: Lag Time (Tlag) of H021
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
SAD Part: Residual area of H021
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
SAD Part: Terminal elimination half-life (T1/2 el) of H021
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
SAD Part: Terminal elimination rate constant (Kel) of H021
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
SAD Part: Apparent clearance (CL/F) of H021
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
SAD Part: Apparent volume of distribution (Vz/F) of H021
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
SAD Part: Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t) of H021
Timepoint [11] 0 0
pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
Secondary outcome [12] 0 0
SAD Part: Maximal Rate of Urinary Excretion (Rmax) of H021
Timepoint [12] 0 0
pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
Secondary outcome [13] 0 0
SAD Part: Time of Maximal Urinary Excretion (TRmax) of H021
Timepoint [13] 0 0
pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
Secondary outcome [14] 0 0
SAD Part: Renal Clearance (CLR) of H021
Timepoint [14] 0 0
pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
Secondary outcome [15] 0 0
MAD Part: Area under the concentration-time curve from time zero to time 24 hours (AUC0-24) of H021
Timepoint [15] 0 0
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
Secondary outcome [16] 0 0
MAD Part: Cmax of H021
Timepoint [16] 0 0
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
Secondary outcome [17] 0 0
MAD Part: Tmax of H021
Timepoint [17] 0 0
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
Secondary outcome [18] 0 0
MAD Part: Area under the concentration-time curve for one dosing interval (t) at steady- state (AUC0-t) of H021
Timepoint [18] 0 0
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
Secondary outcome [19] 0 0
MAD Part: Cmax ss of H021
Timepoint [19] 0 0
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
Secondary outcome [20] 0 0
MAD Part: Tmax ss of H021
Timepoint [20] 0 0
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
Secondary outcome [21] 0 0
MAD Part: Minimal observed concentration at steady-state (Cmin ss) of H021
Timepoint [21] 0 0
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
Secondary outcome [22] 0 0
MAD Part: AUC0-t of H021
Timepoint [22] 0 0
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
Secondary outcome [23] 0 0
MAD Part: AUC0-inf of H021
Timepoint [23] 0 0
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
Secondary outcome [24] 0 0
MAD Part: Residual area of H021
Timepoint [24] 0 0
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
Secondary outcome [25] 0 0
MAD Part: T½ el of H021
Timepoint [25] 0 0
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
Secondary outcome [26] 0 0
MAD Part: Kel of H021
Timepoint [26] 0 0
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
Secondary outcome [27] 0 0
MAD Part: Apparent clearance at steady-state (Clss/F) of H021
Timepoint [27] 0 0
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
Secondary outcome [28] 0 0
MAD Part: Apparent volume of distribution at steady-state (Vz ss/F) of H021
Timepoint [28] 0 0
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
Secondary outcome [29] 0 0
MAD Part: Accumulation ratio (RAUC)
Timepoint [29] 0 0
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
Secondary outcome [30] 0 0
MAD Part: Accumulation Ratio (RCmax)
Timepoint [30] 0 0
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

Eligibility
Key inclusion criteria
1. 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).
2. Healthy as defined by:

1. the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
3. Female participants of non-childbearing potential must be:

1. 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
2. surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or bilateral tubal occlusion) at least 3 months prior to dosing.
4. Participants must be willing not to donate sperm for 90 days or ova (egg) for 6 months after the last dose.
5. Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
6. Able to understand the study procedures and provide signed informed consent to participate in the study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any clinically significant abnormal finding at physical examination.
2. 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.
3. Positive pregnancy test or lactating female participant.
4. Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -1.
5. History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
6. 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.
7. History of drug abuse within 1 year prior to screening as determined by the investigator.
8. 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%).
9. 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.
10. History of clinically significant opportunistic infection (example, invasive candidiasis or pneumocystis pneumonia).
11. History of serious local infection (example, cellulitis, abscess) or systemic infection (example, septicemia) within 3 months prior to screening.
12. 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.
13. Use of medications within the timeframes specified.
14. 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.
15. 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.
16. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/02/2025
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Ply Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Jiangsu Carephar Pharmaceutical Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dr. Ofer Gonen
Address 0 0
Country 0 0
Phone 0 0
0385939801
Fax 0 0
Email 0 0
o.gonen@nucleusnetwork.com.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06627556