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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-08

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis (RA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR-3045 Group

Group Type EXPERIMENTAL

SHR-3045 Injection

Intervention Type DRUG

SHR-3045 injection.

SHR-3045 Placebo Group

Group Type PLACEBO_COMPARATOR

SHR-3045 Placebo Injection

Intervention Type DRUG

SHR-3045 placebo injection.

Interventions

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SHR-3045 Injection

SHR-3045 injection.

Intervention Type DRUG

SHR-3045 Placebo Injection

SHR-3045 placebo injection.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes