Clinical Trials in China / NCT07698756
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Phase 1
A Clinical Study of HRS-8797 in Healthy Participants
NCT07698756 · tracked via the Priya Life Science China tracker
Condition(s) studied
Atopic Dermatitis
Investigational drug(s) / intervention(s)
HRS-8797Placebo
HRS-8797: Specified dose on specified days
Placebo: Specified dose on specified days
Study summary
The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-8797 in healthy participants.
Eligibility
Inclusion Criteria:
1. Healthy men and women aged 18 to 55 years old at informed consent signing
2. Male body weight ≥50 kg , female ≥45 kg; BMI 18 to 28 kg/m² at screening and baseline
3. Have no clinically significant abnormalities at screening and baseline
4. Fertile females and males with fertile female partners: effective contraception consent, and sustained until 4 weeks after the last dose (abstinence or highly effective contraception); no sperm/egg donation
Exclusion Criteria:
1. A history or current severe diseases of multiple systems, or other diseases interfering with trial results.
2. Severe infection, trauma, major surgery within 3 months before screening; planned surgery during the trial.
3. Blood donation/severe blood loss (≥400 mL) within 3 months, blood transfusion within 4 weeks before screening; planned blood donation during the trial.
4. History of drug abuse/dependence; positive urine drug test at screening. Participation in other clinical trials within 3 months before screening or planned
5. participation during the trial; within 5 half-lives of a prior drug (whichever is longer).
6. Smoking history (≥5 cigarettes/day) within 4 weeks before screening; inability to abstain from tobacco during the trial;
7. Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening.
8. Special dietary requirements and inability to comply with the unified diet.
9. Difficulty in swallowing/venous blood collection; intolerance to intensive blood sampling.
10. Other circumstances deemed unsuitable for trial participation by Researcher.
Primary outcome measure(s)
- Safety: incidence of adverse event (AE), serious adverse event (SAE) — Day1-Day15 (SAD);Day1-Day15 (FE);Day1-Day21 (MAD)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin |
More Chengdu Suncadia Medicine Co., Ltd. trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07698756 on ClinicalTrials.gov ↗ ← All trials in China