A Clinical Study of HRS-8797 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-8797, Placebo.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect Following Single and Multiple Oral Doses of HRS-8797 Tablets in Healthy Subjects
Overview
The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-8797 in healthy participants.
Interventions
- Drug HRS-8797
Specified dose on specified days - Drug Placebo
Specified dose on specified days
Primary outcome measures
- Safety: incidence of adverse event (AE), serious adverse event (SAE) [Time frame: Day1-Day15 (SAD)；Day1-Day15 (FE)；Day1-Day21 (MAD)]
Secondary outcome measures (4)
- PK parameter of HRS-8797 : Area under the concentration time curve (AUC) [Time frame: Days 1-19]
- PK parameter of HRS-8797: Maximum Plasma Concentration (Cmax) [Time frame: Days 1-19]
- PK parameter of HRS-8797 : Time to maximum plasma concentration (Tmax) [Time frame: Days 1-19]
- PK parameter of HRS-8797 : Apparent clearance (CL/F) [Time frame: Days 1-19]
Eligibility criteria
Inclusion criteria
- Healthy men and women aged 18 to 55 years old at informed consent signing
- Male body weight ≥50 kg , female ≥45 kg; BMI 18 to 28 kg/m² at screening and baseline
- Have no clinically significant abnormalities at screening and baseline
- 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
- A history or current severe diseases of multiple systems, or other diseases interfering with trial results.
- Severe infection, trauma, major surgery within 3 months before screening; planned surgery during the trial.
- Blood donation/severe blood loss (≥400 mL) within 3 months, blood transfusion within 4 weeks before screening; planned blood donation during the trial.
- History of drug abuse/dependence; positive urine drug test at screening. Participation in other clinical trials within 3 months before screening or planned
- participation during the trial; within 5 half-lives of a prior drug (whichever is longer).
- Smoking history (≥5 cigarettes/day) within 4 weeks before screening; inability to abstain from tobacco during the trial;
- Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening.
- Special dietary requirements and inability to comply with the unified diet.
- Difficulty in swallowing/venous blood collection; intolerance to intensive blood sampling.
- Other circumstances deemed unsuitable for trial participation by Researcher.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Hospital of Jilin University — Changchun
Identifiers
NCT: NCT07698756 · HRS-8797-101