Evaluating the safety and effects of SHR-3045 in healthy individuals

A Phase Ⅰ, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects

This study is testing a new drug called SHR-3045 in healthy people to see how it works in the body and if it has any side effects before trying it in patients with rheumatoid arthritis.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (industry)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06883695 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-3045, an investigational drug, in healthy subjects. Participants will receive either the SHR-3045 injection or a placebo to determine how the drug behaves in the body and its potential side effects. The study will involve a thorough evaluation of participants' health and adherence to specific dietary requirements throughout the trial. By focusing on healthy individuals, the trial seeks to establish a foundational understanding of the drug's effects before it is tested in patients with rheumatoid arthritis.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18-55 who meet specific weight and health criteria.

Not a fit: Patients with a history of drug abuse or those unable to adhere to dietary requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of SHR-3045's safety profile, paving the way for its use in treating rheumatoid arthritis.

How similar studies have performed: While this specific approach is focused on a new drug, similar studies evaluating the safety of investigational drugs in healthy subjects have shown success in the past.

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.
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

Shanghai, Shanghai

• Shanghai General Hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Junlin Huang

Conditions: Rheumatoid Arthritis