Healthy Participants
Conditions
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.
Interventions
DRUGHL-1186
HL-1186 tablet for oral administration.
DRUGHL-1186 placebo
HL-1186 placebo tablet for oral administration.
Sponsors
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and tolerability of single and multiple doses of HL-1186 in healthy participants | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Time to reach maximum concentration (Tmax) |
Countries
China
Contacts
Primary ContactKangli Ma
Outcome results
None listed