RecruitingPhase 1NCT06912295

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

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of HL-1186 in Healthy Participants

Sponsor

Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.

Enrollment

76 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Participants

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

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

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 Criteria6

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.