A Trial of SHR-2173 in Healthy Volunteers

Atridia

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: Immunology

Treatments: Drug: SHR-2173 Injection/SHR-2173 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07390747

SHR-2173-106

Details and patient eligibility

About

The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of SHR-2173 in healthy participants

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion criteria

1. Healthy white participants.
2. Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
3. Male aged between 18 to 45 years of age (inclusive)
4. Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive) at screening.
5. Men and WOCBP must agree to take highly effective contraceptive methods

Main exclusion Criteria

1. History or evidence of clinically significant disorders.
2. Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study or same class drug or any component of it.
3. Receipt of medical devices or another investigational drug within 3 months or 5 half-lives, whichever is longer prior to screening.
4. The injection site has abnormalities or is deemed by the investigator as unsuitable for subcutaneous injection.
5. History of excessive smoking in the past 1 month prior to screening
6. History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline.
7. Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups

SHR-2173 single dose

Experimental group

Description:

Single dose of SHR-2173 given subcutaneously

Treatment:

Drug: SHR-2173 Injection/SHR-2173 placebo

SHR-2173 placebo single dose

Experimental group

Description:

Single dose of SHR-2173 placebo given subcutaneously

Treatment:

Drug: SHR-2173 Injection/SHR-2173 placebo