NCT07698756

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1

Timeline
5mo left

Started Jul 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jul 2026Jan 2027

Study Start

First participant enrolled

July 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 13, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Safety: incidence of adverse event (AE), serious adverse event (SAE)

    Day1-Day15 (SAD)；Day1-Day15 (FE)；Day1-Day21 (MAD)

Secondary Outcomes (4)

  • 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

Study Arms (2)

single ascending dose (SAD) cohorts

EXPERIMENTAL

Subjects will be assigned to one of 5-6 planned dose cohorts and receive single dose of HRS-8797 or placebo

Drug: HRS-8797Drug: Placebo

multiple ascending dose (MAD) cohorts

EXPERIMENTAL

Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-8797 or placebo

Drug: HRS-8797Drug: Placebo

Interventions

HRS-8797DRUG

Specified dose on specified days

multiple ascending dose (MAD) cohortssingle ascending dose (SAD) cohorts
PlaceboDRUG

Specified dose on specified days

multiple ascending dose (MAD) cohortssingle ascending dose (SAD) cohorts

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Beibei Xu

CONTACT

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

Hongda Lin

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

July 13, 2026

Record last verified: 2026-06

Locations

CN(1)