A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2303 in Healthy Adult
A Randomized, Double-blind, Placebo-controlled of GR2303 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2303
1 other identifier
interventional
64
1 country
1
Brief Summary
he goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2303 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2303 injection or placebo administration, with each Subjects will be enrolled in only one of these groups
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2025
CompletedFirst Submitted
Initial submission to the registry
September 22, 2025
CompletedFirst Posted
Study publicly available on registry
September 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 16, 2026
September 30, 2025
September 1, 2025
1 year
September 22, 2025
September 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events
16 weeks
Secondary Outcomes (4)
Cmax
16 weeks
Tmax
16 weeks
t 1/2
16 weeks
ADA
16 weeks
Study Arms (8)
group 1
EXPERIMENTALsingle dose
group 2
EXPERIMENTALsingle dose
group 3
EXPERIMENTALsingle dose
group 4
EXPERIMENTALsingle dose
group 5
EXPERIMENTALsingle dose
group 6
EXPERIMENTALmultiple dose
group 7
EXPERIMENTALmultiple dose
group 8
EXPERIMENTALmultiple dose
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adult subjects
- Signed informed consent
You may not qualify if:
- History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
- Prior use of drug targeting TNF-like cytokine 1A
- history of malignant tumor
- psitive results for Hepatitis B surface antigen (HBsAg), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Friendship hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2025
First Posted
September 30, 2025
Study Start
September 18, 2025
Primary Completion (Estimated)
September 18, 2026
Study Completion (Estimated)
December 16, 2026
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share