Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes
Led by Chengdu Suncadia Medicine Co., Ltd. · Updated on 2025-12-03
66
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS-3095 oral administration in healthy subjects. This study will also explore food effect and the effect of HRS-3095 on CYP3A4 metabolic enzymes.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to comprehend and willing to sign an informed consent form
- Male and female healthy subjects aged 18 to 55 years
- Body mass index between 18.0 and 32.0 kg/m2
- Body weight at least 50 kg for men and 45 kg for women
- No clinically significant abnormalities in health
- Women of childbearing potential must agree to use effective contraception methods
You will not qualify if you...
- History or presence of circulatory, endocrine, neurological, digestive, respiratory, hematological, immunological, psychiatric diseases, metabolic disorders, or other conditions that could interfere with the trial
- Any disease affecting drug absorption, distribution, metabolism, or excretion
- History of recurrent drug allergies or treatment-requiring allergic diseases, or known allergy to any investigational product component
- Infection requiring systemic antimicrobial therapy within 2 weeks before screening or dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Frist Clinical Medicial College of Qingdao University
Qingdao, Shandong, China, 266555
Actively Recruiting
Research Team
H
Hongda Lin
CONTACT
Y
Yifan Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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