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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: HL-1186; Drug: HL-1186 placebo

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kangli Ma; Phone Number: 021-64311017; Email: clinical_trial@hllife.com.cn

Study Locations

• China
  • Wuxi, China
    • Recruiting
    • Jiangnan University Affiliated Hospital
    • Contact: Jiangnan University Affiliated Hospital; Phone Number: 13358100007; Email: 13358100007@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: HL-1186; HL-1186 tablet for oral administration.
Placebo Comparator: 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	Drug: HL-1186 placebo; HL-1186 placebo tablet for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the pharmacokinetic parameters of HL-1186 in healthy participants	Time to reach maximum concentration (Tmax)	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	Maximum concentration (Cmax)	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	Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)	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	Elimination half time (T1/2)	Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2025
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): October 9, 2025

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 30, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PY-HL-1186-I-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No