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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorShanghai Yidian Pharmaceutical Technology Development Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • HL-1186
  • HL-1186 placebo

Treatment groups

76 Participants
are divided into 2 treatment groups