HS-10542 Study in Healthy Participants
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
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
Qualifiers
Male or female between 18 and 64 years of age (critical values inclusive) when signing the informed consent form.
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.
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;
Male participants of childbearing potential are required to agree to practice highly effective contraception from the date of signing the informed consent until 120 days after the last dose; male participants of non-childbearing potential (e.g, having undergone effective sterilization) are required to agree to use additional highly effective contraception in the event of uncertainty about the presence of sperm.
Disqualifiers
Consumed any caffeinated, tea, alcohol, xanthine-rich foods or beverages within 24 hours before administration.
Consumed foods known to alter hepatic enzyme activity (eg, pitaya, grapefruit, Seville oranges, etc) and their juice drinks within 1 week before administration.
Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin (TBiL) ≥ 1.5 times ULN.
Abnormal renal function: eGFR < 60 mL/min/1.73 m2 at screening or abnormal renal function as judged by the investigator, calculated using the estimation formula of Chronic Kidney Disease Epidemiology Collaboration 2021 (CKD-EPI): eGFR (mL/min/1.73 m2) .
Trial design
Treatments tested in this trial
- HS-10542
- HS-10542 Placebo
- HS-10542
- HS-10542 Placebo
Treatment groups
100 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov