Actively Recruiting
A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants
Led by Jiangsu Carephar Pharmaceutical Co., Ltd. · Updated on 2024-10-04
64
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female non-smokers aged 18 to 55 years with a body mass index between 18.5 and 32.0 kg/m2
- Healthy with no significant illness or surgery within 4 weeks before dosing
- No significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disease
- Female participants of non-childbearing potential must be post-menopausal with confirmed hormone levels or surgically sterile at least 3 months before dosing
- Willingness not to donate sperm for 90 days or eggs for 6 months after last dose
- Sexually active females of childbearing potential and non-sterile males must agree to use acceptable contraception during the study
- Ability to understand and sign informed consent
You will not qualify if you...
- Any clinically significant abnormal physical exam findings
- Abnormal laboratory test results including blood, urine, or infection screenings
- Positive pregnancy test or lactation
- Positive drug, cotinine, or alcohol tests at screening or Day -1
- History of serious allergic reactions to any drug
- Abnormal ECG or vital signs outside specified limits
- History of drug or alcohol abuse within 1 year before screening
- History of active or latent tuberculosis except treated latent cases
- History of serious opportunistic or local/systemic infections within specified times
- Fever above 37.5°C within 2 weeks before dosing
- Use of prohibited medications within specified timeframes
- Participation in other clinical research involving drugs or devices recently
- Recent significant blood or plasma donation
- Any other condition deemed by the investigator to prevent study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nucleus Network Ply Ltd.
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
D
Dr. Ofer Gonen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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