Assessing the safety and tolerability of HL-1186 in healthy individuals

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

This study is testing a new oral tablet called HL-1186 in healthy people to see if it is safe and how well it is tolerated compared to a placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Shanghai Huilun Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Wuxi)
• Trial ID: NCT06912295 on ClinicalTrials.gov

What this trial studies

This is a single-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of the oral HL-1186 tablet in healthy participants. The study involves two parts and includes both an active treatment group receiving HL-1186 and a placebo group. Participants will undergo various health assessments to ensure they meet the eligibility criteria and to monitor their health throughout the study.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18 to 45 years with specific weight and BMI criteria.

Not a fit: Patients who are pregnant, breastfeeding, or have a history of significant health disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the safety and tolerability of HL-1186, paving the way for its potential use in future treatments.

How similar studies have performed: While this study focuses on a specific drug, similar studies assessing the safety and pharmacokinetics of new medications in healthy participants have shown success in the past.

Eligibility criteria

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.

Where this trial is running

Wuxi

• Jiangnan University Affiliated Hospital — Wuxi, China (Recruiting)

Study contacts

• Study coordinator: Kangli Ma

Conditions Healthy Participants