Actively Recruiting
Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants
Led by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. · Updated on 2025-08-24
76
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-center, randomized, double-blind, placebo-controlled, two-part study is designed to assess the safety, tolerability and PK of oral HL-1186 Tablet in healthy participants.
CONDITIONS
Official Title
Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females
- Aged between 18 and 45 years old (inclusive)
- Males weighing at least 50 kg; females weighing at least 45 kg
- Body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive)
- Normal or clinically insignificant results in vital signs, physical exam, blood tests, coagulation, urine tests, virology, chest X-ray, and pregnancy test during screening (for females)
You will not qualify if you...
- Females who are pregnant or breastfeeding
- Females or males planning to have children
- History or presence of neurological, cardiovascular, kidney, liver, stomach, lung, blood, hormone, or bone/joint disorders, or lab abnormalities that pose risk or interfere with data
- Active infections requiring treatment
- Major surgery within the past three months without full recovery
- Significant allergies including to study drug components, asthma attacks, or atopic reactions
- Immunosuppressive diseases such as immunodeficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jiangnan University Affiliated Hospital
Wuxi, China
Actively Recruiting
Research Team
K
Kangli Ma
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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