Recruiting NCT06912295
Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HL-1186, HL-1186 placebo.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of HL-1186 in Healthy Participants
Overview
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.
Interventions
- Drug HL-1186
HL-1186 tablet for oral administration. - Drug HL-1186 placebo
HL-1186 placebo tablet for oral administration.
Primary outcome measures
- 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]
Secondary outcome measures (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]
- 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]
- 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]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Jiangnan University Affiliated Hospital — Wuxi
Identifiers
NCT: NCT06912295 · PY-HL-1186-I-01