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A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects

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Hengrui Medicine

Status and phase

Enrolling
Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: SHR-3045 Placebo Injection
Drug: SHR-3045 Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06883695
SHR-3045-101

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.

Enrollment

40 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.
  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

40 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

Trial contacts and locations

1

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Central trial contact

Junlin Huang

Data sourced from clinicaltrials.gov

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