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

Last updated: October 3, 2024
Sponsor: Jiangsu Carephar Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Crohn's Disease

Ulcers

Inflammatory Bowel Disease

Treatment

H021 Placebo

H021

Clinical Study ID

NCT06627556
KFP-2024-H021-HW-101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, non-smoker (no use of tobacco or nicotine products within 3 monthsprior 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:

  3. the absence of clinically significant illness and surgery within 4 weeks priorto study drug administration.

  4. the absence of clinically significant history of neurological, endocrine,cardiovascular, respiratory, hematological, immunological, psychiatric,gastrointestinal, renal, hepatic, and metabolic disease.

  5. Female participants of non-childbearing potential must be:

  6. post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing)with confirmation by documented follicle-stimulating hormone (FSH) levels >=40milli-international units per milliliter (mIU/mL); or

  7. surgically sterile (bilateral oophorectomy, bilateral salpingectomy,hysterectomy, or bilateral tubal occlusion) at least 3 months prior to dosing.

  8. Participants must be willing not to donate sperm for 90 days or ova (egg) for 6months after the last dose.

  9. Sexually active females of childbearing potential and non-sterile males must bewilling to use an acceptable contraceptive method throughout the study.

  10. Able to understand the study procedures and provide signed informed consent toparticipate in the study.

Exclusion

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 resultsfor hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or humanimmunodeficiency virus (HIV) antigen and antibody, or QuantiFERON®-TB test atscreening.

  3. Positive pregnancy test or lactating female participant.

  4. Positive urine drug screen, urine cotinine test, or alcohol breath test at screeningor 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 (systolicblood pressure lower than 90 or over 140 millimetres of mercury (mmHg), diastolicblood pressure lower than 40 or over 90 mmHg, heart rate less than 40 or over 100beats per minute (bpm), respiratory rate less than 10 or over 22 bpm), or oxygensaturation less than 95 percent (%) oxygen at screening.

  7. History of drug abuse within 1 year prior to screening as determined by theinvestigator.

  8. History of alcohol abuse within 1 year prior to screening or regular use of alcoholwithin 1 month prior to screening that exceeds 10 units of alcohol per week forwomen 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 notexclusionary.

  10. History of clinically significant opportunistic infection (example, invasivecandidiasis or pneumocystis pneumonia).

  11. History of serious local infection (example, cellulitis, abscess) or systemicinfection (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 aninvestigational 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 studywithin 90 days prior to the first dosing, or simultaneous participation in aninvestigational study involving no drug or device administration.

  15. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL ormore of whole blood within 8 weeks prior to dosing.

  16. Any reason which, in the opinion of the Investigator, would prevent the participantfrom participating in the study.

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: H021 Placebo
Phase: 1
Study Start date:
September 17, 2024
Estimated Completion Date:
February 27, 2025

Study 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.

Connect with a study center

  • Nucleus Network Ply Ltd.

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

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