Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT06912295

Run by

Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.

People needed

76

Starts

2025-03-21

Expected to finish

2025-10-09

Last updated by the study team

2025-08-24

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Jiangnan University Affiliated Hospital — Wuxi, China (enrolling)

Full record on ClinicalTrials.gov

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