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

Hengrui Medicine

Status and phase: Enrolling; Phase 1

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: SHR-3045 Injection; Drug: SHR-3045 Placebo Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07200596

SHR-3045-102

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

SHR-3045 Group

Experimental group

Treatment:

Drug: SHR-3045 Injection

SHR-3045 Placebo Group

Placebo Comparator group

Treatment:

Drug: SHR-3045 Placebo Injection