A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants

NCT06627556 | Recruiting Phase 1

• 1 other identifier: KFP-2024-H021-HW-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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

Other Outcomes (2)

• MAD Part: Change From Baseline in Micro-RNA-124 (miR-124) Expression in Peripheral Blood Mononuclear Cells (PBMCs)

  Day 1 at predose, and at 12 hours, on Day 5 at predose, and on Day 7 at predose, and at 12 hours post-last dose

• MAD Part: Change From Baseline in Interleukin (IL)-6, Tumor Necrosis Factor Alpha (TNF-α), IL-17A, and Interferon Gamma (IFN-γ) in Blood Serum

  Day 1 at predose, and at 12 hours, on Day 5 at predose, and on Day 7 at predose, and at 12 hours post-last dose

Study Arms (10)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Drug: H021 Placebo

Interventions

H021 DRUG

H021 oral tablet.

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 Placebo DRUG

H021 placebo oral tablet.

MAD-H021 Placebo; SAD-H021 Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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 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.

Sponsors & Collaborators

• Jiangsu Carephar Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Nucleus Network Ply Ltd.

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Dr. Ofer Gonen

CONTACT

0385939801; o.gonen@nucleusnetwork.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 4, 2024
• Study Start: September 17, 2024
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)