A Trial of HRS-9813 in Healthy Volunteers

Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Study ID
NCT06514963
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • HRS-9813 — 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 and pharmacokinetics of HRS-9813 in healthy volunteers.

Key Dates

First listed
Jul 23, 2024
Start date
Jul 24, 2024
Status verified
Jul 2024
Primary completion
Jan 2, 2025
Completion
Jan 2, 2025

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: single ascending dose (SAD) cohorts
    Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-9813 or placebo
  • Experimental: multiple ascending dose (MAD) cohorts
    Subjects will be assigned to one of 3-4 planned dose cohorts and receive multiple doses of HRS-9813 or placebo

Primary Outcome Measure

Safety: incidence of adverse event (AE), serious adverse event (SAE) [ Time Frame: 7 days (SAD), 14 days (MAD) ]

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