A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
NCT ID: NCT06883695
Last Updated: 2025-08-12
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2025-04-08
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SHR-3045 Group
SHR-3045 Injection
SHR-3045 injection.
SHR-3045 Placebo Group
SHR-3045 Placebo Injection
SHR-3045 placebo injection.
Interventions
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SHR-3045 Injection
SHR-3045 injection.
SHR-3045 Placebo Injection
SHR-3045 placebo injection.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
Yes
Sponsors
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Guangdong Hengrui Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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SHR-3045-101
Identifier Type: -
Identifier Source: org_study_id
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