Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants

Shanghai Yidian Pharmaceutical Technology Development

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: HL-1186 placebo; Drug: HL-1186

Study type: Interventional

Funder types: Industry

Identifiers

NCT06912295

PY-HL-1186-I-01

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

HL-1186

Experimental group

Description:

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

Treatment:

Drug: HL-1186

HL-1186 placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: HL-1186 placebo