The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of SHR-3045 in Healthy Subjects

Last updated: November 13, 2025
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Rheumatoid Arthritis

Treatment

SHR-3045 Placebo Injection

SHR-3045 Injection

Clinical Study ID

NCT07200596
SHR-3045-102
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single-dose subcutaneous injection of SHR-3045 in healthy subjects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects with ability to understand the trial procedures and possible adverseevents, voluntary participation in the trial.

  2. Subjects who can provide written informed consent.

  3. Males or females aged 18-55 years (both inclusive).

  4. Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg, body mass index (BMI) 19-28 kg/m2 (both inclusive).

  5. No clinically significant abnormalities in the medical history, general physicalexaminations, vital signs and laboratory tests.

Exclusion

Exclusion Criteria:

  1. Participation in clinical trials of other investigational drugs or medical deviceswithin 3 months prior to screening.

  2. Known or suspected history of drug abuse.

  3. Addiction to tobacco and alcohol.

  4. Individuals who are unable to adhere to the dietary requirements of this trialduring the study period.

  5. Judged by the investigator, there are any other conditions that interfere with theresults evaluation of the trial.

Study Design

Total Participants: 16
Treatment Group(s): 2
Primary Treatment: SHR-3045 Placebo Injection
Phase: 1
Study Start date:
October 08, 2025
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hefei 1808722, Anhui 1818058 230001
    China

    Active - Recruiting

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