NCT06627556 A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants
| NCT ID | NCT06627556 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiangsu Carephar Pharmaceutical Co., Ltd. |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-09-17 |
| Primary Completion | 2025-02-27 |
Trial Parameters
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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.
Eligibility Criteria
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, bilater
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