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

Not Applicable

Not yet recruiting

• Conditions: Rheumatoid Arthritis (RA)
• Interventions: Drug: SHR-3045 Injection; Drug: SHR-3045 Placebo Injection

• Registration Number: NCT07200596
• Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study Start: 2025-10-01
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Subjects with ability to understand the trial procedures and possible adverse events, 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 physical examinations, vital signs and laboratory tests.

Exclusion Criteria

1. Participation in clinical trials of other investigational drugs or medical devices within 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 trial during the study period.
5. Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-3045 Group	SHR-3045 Injection	-
SHR-3045 Placebo Group	SHR-3045 Placebo Injection	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	From screening period up to Day 113.

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last).	Post-dose at Day 1 to Day 113.
Maximum observed concentration of SHR-3045 (Cmax).	Post-dose at Day 1 to Day 113.
Time to maximum observed concentration of SHR-3045 (Tmax).	Post-dose at Day 1 to Day 113.
Apparent clearance of SHR-3045 (CL/F).	Post-dose at Day 1 to Day 113.
Apparent volume of distribution of SHR-3045 (Vz/F).	Post-dose at Day 1 to Day 113.
Terminal elimination half-life of SHR-3045 (t1/2).	Post-dose at Day 1 to Day 113.
Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf).	Post-dose at Day 1 to Day 113.

Trial Locations

Locations (1)

The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital); 🇨🇳 Hefei, Anhui, China