Actively Recruiting
HS-10542 Study in Healthy Participants
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2025-06-26
100
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HS-10542 Study in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 64 years old at signing informed consent
- Body mass index (BMI) between 19 and 28 kg/m2 at screening
- Body weight at least 50 kg for men and at least 45 kg for women
- Normal or clinically insignificant physical exam, lab tests, ECG, abdominal ultrasound, chest X-ray or CT as judged by investigator
- Female participants agree to use highly effective contraception from 2 weeks before screening until 60 days after last dose
- Male participants of childbearing potential agree to use highly effective contraception from consent until 120 days after last dose; non-childbearing males agree to additional contraception if sperm presence is uncertain
- Completed or able to complete vaccinations for Neisseria meningitidis (types A, C, Y, W-135) and streptococcus pneumoniae at least 2 weeks before first dose or provide antibody/vaccine info
- Able to communicate clearly, understand and comply with trial requirements, and voluntarily sign informed consent
You will not qualify if you...
- Consumed caffeine, tea, alcohol, xanthine-rich foods or beverages within 24 hours before administration
- Consumed foods or juices that alter liver enzymes (eg, pitaya, grapefruit, Seville oranges) within 1 week before administration
- Clinically significant abnormal vital signs, physical exam, lab tests, ECG, chest X-ray/CT, or abdominal ultrasound at screening
- Abnormal liver function tests: ALT, AST, or total bilirubin ≥ 1.5 times upper limit of normal
- Abnormal kidney function: eGFR below 60 mL/min/1.73 m2 or as judged by investigator
- Abnormal ECG: QTcF > 450 msec for males or > 470 msec for females, or other significant abnormalities
- Positive tests for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, HIV antibody, or Treponema pallidum antibody deemed unsuitable for participation
- Active, inactive, or latent tuberculosis infection judged inappropriate for study
- Positive pregnancy test, breastfeeding, or planning pregnancy during trial
- Use of systemic medications or foods affecting drug metabolism within washout period prior to screening or unwilling to discontinue during trial
- Vaccinated with non-protocol vaccines within 1 month before screening or scheduled within 1 month after study end
- Participation in another clinical trial with investigational product within 1 month or 7 half-lives prior to screening
- Blood donation or loss of ≥ 450 mL within 3 months prior to screening or planned during/after trial
- Smoking more than 5 cigarettes per day within 3 months prior to screening
- Diseases affecting oral drug absorption or metabolism within 3 months prior to screening
- History of drug abuse within 6 months or positive drug abuse test at screening
- History of alcohol dependence or positive breath alcohol test within 6 months
- Major surgery (Grade 2 or higher) within 6 months or planned surgery/hospitalization during trial
- History of severe allergies or hypersensitivity to investigational product or excipients
- History of capsular microorganism infections or close contact with infected individuals
- Difficulty swallowing tablets or capsules
- Difficulty or contraindications to blood collection
- Special dietary requirements or inability to comply with study diet
- Any other diseases or conditions increasing risk or affecting compliance or completion as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
Research Team
Y
Yu Cao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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