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

Phase 1

Recruiting

• Conditions: Healthy Participants
• Interventions: Drug: HL-1186; Drug: HL-1186 placebo

• Registration Number: NCT06912295
• Lead Sponsor: Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-21
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-30
• Study First Posted: 2025-04-04
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-24
• Primary Completion: 2025-08-30
• Study Completion: 2025-10-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Healthy participants, males and females.
2. Between the ages of 18 and 45 years old (inclusive).
3. 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).
4. 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 Criteria

1. Females who are pregnant or breastfeeding; females/males who are prepared for having children.
2. 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.
3. Active infectious diseases which need anti-infection treatment.
4. Significant surgery within three months and not fully recovered per investigator's judgments.
5. 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.
6. Immunosuppressive diseases, e.g., immunodeficiency, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HL-1186	HL-1186	Single dose ascending(SAD): participants will be randomized to receive a single dose of HL-1186 or placebo,dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort Food effect(FE): participants will be randomized to group A or group B, to evaluate different fed conditions on the PK of HL-1186 Multiple ascending dose(MAD): participants will be randomized to receive Muliple doses of HL-1186 or placebo, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort
HL-1186 placebo	HL-1186 placebo	Single dose ascending(SAD): participants will be randomized to receive a single dose of HL-1186 or placebo,dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort Food effect(FE): participants will be randomized to group A or group B, to evaluate different fed conditions on the PK of HL-1186 Multiple ascending dose(MAD): participants will be randomized to receive Muliple doses of HL-1186 or placebo, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of single and multiple doses of HL-1186 in healthy participants	Single ascending dose(SAD): day1 to day14; Food effect(FE): day1 to day21; Multiple ascending dose(MAD): day1 to day27	Number of participants with adverse events, with abnormal physical examination finding, with abnormal vital signs, abnormal 12-lead electrocardiograms and abnormal laboratory tests results (hematology, urinalysis, clinical chemistry, coagulation function

Secondary Outcome Measures

Name	Time	Method
To assess the pharmacokinetic parameters of HL-1186 in healthy participants	Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20	Elimination half time (T1/2)

Trial Locations

Locations (1)

Jiangnan University Affiliated Hospital; 🇨🇳 Wuxi, China