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Starting soon Phase 1

A Clinical Study of HRS-8797 in Healthy Participants

NCT07698756 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2026-07
Last updated
2026-07-13

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

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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)

FacilityCityRegionStatus
The First Hospital of Jilin University Changchun Jilin
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