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

NCT06912295 | Recruiting Phase 1

• 1 other identifier: PY-HL-1186-I-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of single and multiple doses of HL-1186 in healthy participants

  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

  Single ascending dose(SAD): day1 to day14; Food effect(FE): day1 to day21; Multiple ascending dose(MAD): day1 to day27

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

HL-1186

EXPERIMENTAL

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

Drug: HL-1186

HL-1186 placebo

PLACEBO COMPARATOR

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

Drug: HL-1186 placebo

Interventions

HL-1186 DRUG

HL-1186 tablet for oral administration.

HL-1186

HL-1186 placebo DRUG

HL-1186 placebo tablet for oral administration.

HL-1186 placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.: lead

Study Sites (1)

Jiangnan University Affiliated Hospital

Wuxi, China

RECRUITING

Central Study Contacts

Kangli Ma

CONTACT

021-64311017; clinical_trial@hllife.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 4, 2025
• Study Start: March 21, 2025
• Primary Completion: August 30, 2025
• Study Completion: October 9, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)