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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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HS-10542

    Drug

    1. SAD：HS-10542 capsule (5 predefined dose cohorts ) will be administered orally once on Day 1. 2. Food Effect \[FE\] study：HS-10542 capsule (in one predefined dose cohort ) will be administered orally once on Day 15.

  • HS-10542 Placebo

    Drug

    SAD：HS-10542 capsule placebo (5 predefined dose cohorts ) will be administered orally once on Day 1

  • HS-10542

    Drug

    MAD：HS-10542 capsule (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 10.

  • HS-10542 Placebo

    Drug

    MAD：HS-10542 capsule placebo (5 predefined dose cohorts ) will be administered orally once or twice from Day 1 to Day 10.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Cohort1：HS-10542 SAD：HS-10542 capsuleExperimental treatment 1 intervention
Group B: Cohort2：HS-10542 Placebo SAD：HS-10542 capsule placeboPlacebo comparator 1 intervention
Group C: Cohort3：HS-10542 MAD：HS-10542 capsuleExperimental treatment 1 intervention
Group D: Cohort4：HS-10542 Placebo MAD：HS-10542 capsule placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs) and the changes in clinical test and examination results

The incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events leading to withdrawal from the study, as well as their correlation with the investigational drug.And the changes in clinical test and examination results before and after administration

Time frame
From screening to day 11 or day 21.

Secondary outcomes

1

Pharmacokinetics (PK) parameters：Observed maximum plasma concentration（Cmax）

The plasma PK parameters to be determined after the first dose in the single ascending dose (SAD) and food effect (FE) studies

Time frame
up to 240 hours after dosing
2

Pharmacokinetics (PK) parameters：Time to reach maximum plasma concentration(Tmax）

The plasma PK parameters to be determined after the first dose in the single ascending dose (SAD) and food effect (FE) studies

Time frame
up to 240 hours after dosing
3

Pharmacokinetics (PK) parameters：area under the concentration-time curve from time 0 to time t of last measurable concentration( AUC0-t)

The plasma PK parameters to be determined after the first dose in the single ascending dose (SAD), food effect (FE), and multiple ascending dose (MAD) studies

Time frame
up to 240 hours after dosing
4

PK parameters: Maximum plasma concentration at steady state (Css, max)

The plasma PK parameters to be determined after the last dose in the MAD study

Time frame
up to 240 hours after dosing

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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