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NCT Number: NCT06912295

Assess the Safety, Tolerability, and Pharmacokinetics 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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jiangnan University Affiliated Hospital

Wuxi, China

Location status: Recruiting

Location contact

Jiangnan University Affiliated Hospital

CONTACT

[email protected]

13358100007

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

HL-1186

Drug

HL-1186 tablet for oral administration.

HL-1186 placebo

Drug

HL-1186 placebo tablet for oral administration.

Primary outcomes

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

    Time frame: 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 outcomes

  1. To assess the pharmacokinetic parameters of HL-1186 in healthy participants

    Time frame: Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20

    Time to reach maximum concentration (Tmax)

  2. To assess the pharmacokinetic parameters of HL-1186 in healthy participants

    Time frame: Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20

    Maximum concentration (Cmax)

  3. To assess the pharmacokinetic parameters of HL-1186 in healthy participants

    Time frame: Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20

    Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)

  4. To assess the pharmacokinetic parameters of HL-1186 in healthy participants

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Kangli Ma

CONTACT

[email protected]

021-64311017

Sponsors and collaborators

Lead sponsor

Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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