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Clinical trial

A Randomized, Double-blind, Placebo-controlled, Single-dose Administration of GR2102 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2102

ID
Name
GR2102-001
Description
the goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be enrolled in only one of these groups。
Trial arms
Trial start
2024-03-24
Estimated PCD
2025-01-06
Trial end
2025-12-06
Status
Not yet recruiting
Phase
Early phase I
Treatment
GR2102 injection
single dose
Arms:
Treatment group 1, Treatment group 2, Treatment group 3, Treatment group 4, Treatment group 5, Treatment group 6
placebo
single dose
Arms:
Treatment group 1, Treatment group 2, Treatment group 3, Treatment group 4, Treatment group 5, Treatment group 6
Size
132
Primary endpoint
Adverse events
150 days post dose
Eligibility criteria
Inclusion Criteria: 1. Healthy adult subjects 2. Signed informed consent Exclusion Criteria: 1. Signs and symptoms of upper respiratory tract infection prior to randomization 2. Prior use of RSV vaccine or RSV antibody-based medications 3. history of malignant tumor
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 132, 'type': 'ESTIMATED'}}
Updated at
2024-03-15

1 organization

2 products

1 indication

Product
GR2102
Indication
Respiratory Syncytial Virus Infections
Organization
Genrix (Shanghai) Biopharmaceutical
Product
placebo