The Study of Single Dose Administration of GR2002 Injection in Chinese Health Volunteers
NCT ID: NCT05954611
Last Updated: 2024-08-22
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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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2023-06-16
2024-01-02
Brief Summary
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Detailed Description
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The initial dose group is 35mg, and the subsequent doses will gradually increase. Only after all subjects in the current dose group have completed at least 2 weeks of safety and tolerance observation and confirmed safe tolerance, can they enter the next dose group for medication observation until the "dose increase termination standard" is reached.
Follow up will be conducted for at least 12 weeks ± 3 days after completion of medication administration.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GR2002 injection
GR2002 subcutaneous injection
GR2002 injection
one single dose of GR2002 injection
placebo
placebo subcutaneous injection
Placebo
one single dose of placebo
Interventions
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GR2002 injection
one single dose of GR2002 injection
Placebo
one single dose of placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
ALL
Yes
Sponsors
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Genrix (Shanghai) Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yi Fang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Peking University People's Hospital
Beijing, , China
Countries
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Other Identifiers
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GR2002-001
Identifier Type: -
Identifier Source: org_study_id
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