A Clinical Study of HRS-8797 in Healthy Participants

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07698756

Enrollment

Registered

2026-07-13

Start date

2026-07-01

Completion date

2027-01-01

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-8797 in healthy participants.

Interventions

DRUGHRS-8797

Specified dose on specified days

DRUGPlacebo

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety: incidence of adverse event (AE), serious adverse event (SAE)	Day1-Day15 (SAD)；Day1-Day15 (FE)；Day1-Day21 (MAD)

Secondary

Measure	Time frame
PK parameter of HRS-8797 : Area under the concentration time curve (AUC)	Days 1-19
PK parameter of HRS-8797: Maximum Plasma Concentration (Cmax)	Days 1-19
PK parameter of HRS-8797 : Time to maximum plasma concentration (Tmax)	Days 1-19
PK parameter of HRS-8797 : Apparent clearance (CL/F)	Days 1-19

Countries

China

Contacts

CONTACTBeibei Xu

beibei.xu.bx53@hengrui.com+86 0518-82342973

CONTACTHongda Lin

hongda.lin@hengrui.com+86 0518-82342973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026