A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants
ConditionUlcerative Colitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorJiangsu Carephar Pharmaceutical Co., Ltd.
About this trial
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
Qualifiers
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/m²).
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.
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- H021
- H021 Placebo
Treatment groups
64 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov