Status:
RECRUITING
Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants
Lead Sponsor:
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Conditions:
Healthy Participants
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Healthy participants, males and females.
- Between the ages of 18 and 45 years old (inclusive).
- Weighs no less than 50 kg (for males) or 45 kg (for females) and body mass index (BMI) within 19.0 to 26.0 kg/m2 (inclusive).
- During the screening period, vital signs, physical examination, blood routine, blood biochemistry, coagulation function, urine routine, virology examination, chest X-ray, and pregnancy blood test (female) were examined, and the results did not show abnormalities or abnormalities without clinical significance.
Exclusion
- Females who are pregnant or breastfeeding; females/males who are prepared for having children.
- History or presence of neurological, cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, or osteoarticular disorders, or any laboratory abnormalities that pose a potential danger to constitute a risk when taking the study intervention or interfere with the interpretation of data.
- Active infectious diseases which need anti-infection treatment.
- Significant surgery within three months and not fully recovered per investigator's judgments.
- Significant allergies per investigator's judgments, e.g., food allergies, allergies, or atopic reactions to any components of the investigational drug or placebo, asthma attacks, etc.
- Immunosuppressive diseases, e.g., immunodeficiency, etc.
Key Trial Info
Start Date :
March 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 9 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06912295
Start Date
March 21 2025
End Date
October 9 2025
Last Update
August 24 2025
Active Locations (1)
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1
Jiangnan University Affiliated Hospital
Wuxi, China