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Recruiting Phase 1 NCT07040046

HS-10542 Study in Healthy Participants

Trial Parameters

Condition Healthy
Sponsor Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 64 Years
Start Date 2025-05-16
Completion 2025-12-04
Interventions
HS-10542HS-10542 PlaceboHS-10542

Brief Summary

This is a randomized, double-blind, placebo-controlled, dose escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and the food effect on the pharmacokinetics of HS-10542 in healthy participants.

Eligibility Criteria

Inclusion Criteria: 1. Male or female between 18 and 64 years of age (critical values inclusive) when signing the informed consent form. 2. Body mass index (BMI = weight/height2) ≥ 19 kg/m2 and ≤ 28 kg/m2 at screening, and body weight ≥ 50 kg for men and ≥ 45 kg for women. 3. Physical examination, laboratory tests, 12-lead ECG, abdominal B-ultrasound and anteroposterior and lateral chest X-ray (or CT) examination showed no abnormality, or slight abnormality but with no clinical significance as judged by the investigator, or slight abnormality but with controllable risk as judged by the investigator, and communication with the sponsor 's medical and pharmacological personnel is required when necessary; 4. Female participants are required to agree to practice highly effective contraception from 2 weeks before screening until 60 days after the last dose: 5. Male participants of childbearing potential are required to agree to practice highly effective contraception from the date of signing

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