Single subcutaneous dose of SHR-3045 in healthy adults

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

This will test whether a single subcutaneous dose of SHR-3045 is safe and how the body absorbs and responds to it in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT07200596 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, placebo-controlled trial gives a single subcutaneous dose of SHR-3045 or placebo to healthy adults to measure safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). Participants are screened for good health, age 18–55, and specified weight/BMI limits before dosing. Study procedures include vital signs, clinical exams, blood sampling for PK/PD, and laboratory safety monitoring over the planned follow-up period. The trial is conducted at The First Affiliated Hospital of USTC (Anhui Provincial Hospital) in Hefei, Anhui, China.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18–55 who meet the study weight and BMI requirements, have no clinically significant medical issues, and can comply with study procedures.

Not a fit: People with active rheumatoid arthritis, significant medical conditions, recent participation in other investigational trials, or substance abuse are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, SHR-3045 could progress toward becoming a new treatment option for people with rheumatoid arthritis by defining a safe dose and dosing profile.

How similar studies have performed: Phase 1 PK/safety studies in healthy volunteers are a standard first step and several RA-targeted therapies with favorable Phase 1 results have advanced, but SHR-3045 itself is novel and has not yet demonstrated patient benefit.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui

• The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital) — Hefei, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Junlin Huang

Conditions Rheumatoid Arthritis