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Completed

NCT Number: NCT07200596

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

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.

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, 230001, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial.
  • Subjects who can provide written informed consent.
  • Males or females aged 18-55 years (both inclusive).
  • Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg, body mass index (BMI) 19-28 kg/m2 (both inclusive).
  • No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.

Exclusion criteria

  • Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.
  • Known or suspected history of drug abuse.
  • Addiction to tobacco and alcohol.
  • Individuals who are unable to adhere to the dietary requirements of this trial during the study period.
  • Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.

Treatment and study plan

SHR-3045 Injection

Drug

SHR-3045 injection.

SHR-3045 Placebo Injection

Drug

SHR-3045 placebo injection.

Primary outcomes

  1. Adverse events (AEs)

    Time frame: From screening period up to Day 113.

Secondary outcomes

  1. Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last).

    Time frame: Post-dose at Day 1 to Day 113.

  2. Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf).

    Time frame: Post-dose at Day 1 to Day 113.

  3. Maximum observed concentration of SHR-3045 (Cmax).

    Time frame: Post-dose at Day 1 to Day 113.

  4. Time to maximum observed concentration of SHR-3045 (Tmax).

    Time frame: Post-dose at Day 1 to Day 113.

  5. Apparent clearance of SHR-3045 (CL/F).

    Time frame: Post-dose at Day 1 to Day 113.

  6. Apparent volume of distribution of SHR-3045 (Vz/F).

    Time frame: Post-dose at Day 1 to Day 113.

  7. Terminal elimination half-life of SHR-3045 (t1/2).

    Time frame: Post-dose at Day 1 to Day 113.

Sponsors and collaborators

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose Subcutaneous Injection of SHR-3045 in Healthy Subjects-A Randomized, Double-Blind, Dose-Escalating, Placebo-Controlled Phase I Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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