A Clinical Study of HRS-8797 in Healthy Participants

Sponsor
Chengdu Suncadia Medicine Co., Ltd.
Study ID
NCT07698756
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • HRS-8797 — DRUG
    Specified dose on specified days
  • Placebo — DRUG
    Specified dose on specified days

Study Details

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

Key Dates

First listed
Jul 13, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: single ascending dose (SAD) cohorts
    Subjects will be assigned to one of 5-6 planned dose cohorts and receive single dose of HRS-8797 or placebo
  • Experimental: multiple ascending dose (MAD) cohorts
    Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-8797 or placebo

Primary Outcome Measure

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

Central Contacts

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