The Safety, Tolerability, and Pharmacokinetics of of SYH9017 in Chinese Participants With Overweight and Obesity

Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Study ID
NCT06830343
Phase
PHASE1
Status
Recruiting
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Conditions

  • Overweight or Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • SYH9017 — DRUG
    subcutaneous injection once time in SAD and four times in MAD
  • Placebo — DRUG
    subcutaneous injection once time in SAD and four times in MAD
  • Wegovy ® — DRUG
    subcutaneous injection once a week

Study Details

This is a randomized, double-blind, single-center, dose-escalation, single ascending dose and multiple ascending dose study of SYH9017 in Chinese participants with overweight and obesity.

Key Dates

Start date
Feb 27, 2025
Status verified
Mar 2026
Primary completion
Aug 1, 2026
Completion
Oct 1, 2026

Study Design

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

Arms

  • Experimental: SYH9017 SAD experimental group
    Subjects in SAD experimental groups will receive a single subcutaneous injection of SYH9017 on Day 1
  • Placebo Comparator: Placebo SAD group
    Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1
  • Experimental: SYH9017 MAD experimental group
    Subjects in MAD experimental groups will receive subcutaneous injection of SYH9017 every 4weeks
  • Placebo Comparator: Placebo MAD group
    Subjects in MAD placebo groups will receive subcutaneous injection of placebo every 4weeks
  • Active Comparator: Positive Control MAD group
    Subjects in MAD active comparator groups will receive subcutaneous injection of placebo every weeks

Primary Outcome Measure

Incidence of AEs following single-dose administration of SYH9017 Description: [ Time Frame: up to 49 days after the dosing ]

Central Contacts

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