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Tests treatment safety and results for Health Services Research
Official title Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects
ClinicalTrials.gov ID: NCT07535099
What this study is testing
What is ICP-538 Tablets?
ICP-538 Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for health services research.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Voluntarily sign the ICF..
- BMI between 18-26 kg/m² (inclusive). Male weight ≥50 kg; female weight ≥45 kg.
- Vital signs, physical examination, ECG, Chest X-ray, Abdominal ultrasound results at screening are within normal range or showing minor deviations...
- Laboratory test results at screening and baseline are within the normal reference range.
- Reproductive Status：Females of non-childbearing potential . Male participants and their partners must agree to use effective contraception throughout...
You likely can't join if
- Evidence or history of clinically significant diseases, or Evidence or history of allergic diseases .
- Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption.
- Acute illness within 14 days before dosing.
- Severe infection within 6 months before dosing, or chronic/recurrent infections.
- Participant and/or first-degree relative with hereditary immunodeficiency.
- Major trauma or surgery within 3 months before dosing.
See the full eligibility criteria
- Voluntarily sign the ICF..
- BMI between 18-26 kg/m² (inclusive). Male weight ≥50 kg; female weight ≥45 kg.
- Vital signs, physical examination, ECG, Chest X-ray, Abdominal ultrasound results at screening are within normal range or showing minor deviations deemed not clinically significant by the investigator.
- Laboratory test results at screening and baseline are within the normal reference range.
- Reproductive Status：Females of non-childbearing potential . Male participants and their partners must agree to use effective contraception throughout the study and for 3 months after the last dose. Male participants...
- Evidence or history of clinically significant diseases, or Evidence or history of allergic diseases .
- Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption.
- Acute illness within 14 days before dosing.
- Severe infection within 6 months before dosing, or chronic/recurrent infections.
- Participant and/or first-degree relative with hereditary immunodeficiency.
- Major trauma or surgery within 3 months before dosing.
- History of active/latent TB or contact with an open TB case within 6 months before dosing.
- Positive urine drug screen.
- Alcohol abuse.
- Use of tobacco/nicotine products within 3 months before the first dose.
- Use of any prescription/non-prescription drugs, herbal medicines, supplements within 14 days before first dose; or systemic corticosteroids, immunosuppressants/modulators, hormone replacement therapy within 30 days...
- Consumption of caffeine-containing foods/beverages within 48 hours before the first dose.
- Use of known CYP3A4 inducers/inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose.
- Dieting, dietary therapy within 30 days before the first dose.
- Positive for syphilis antibody, HCV-Ab, HBsAg, HBcAb, or HIV-Ab at screening.
- Administration of live vaccines within 6 weeks before the first dose or planned during study or within 8 weeks after study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.