A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2303 in Healthy Adult
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GR2303 injection, Placebo, GR2303 injection, Placebo.
- Who it may be relevant to
- Registry conditions: Health Adult Subjects. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Placebo-controlled of GR2303 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2303
Overview
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
Detailed description
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2303 Injection in healthy adult Chinese subjects.
After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number. Subjects will be enrolled in only one of these groups.
Interventions
- Biological GR2303 injection
single dose - Biological Placebo
single dose - Biological GR2303 injection
multiple dose - Biological Placebo
multiple dose
Primary outcome measures
- Adverse events [Time frame: 16 weeks]
Secondary outcome measures (4)
- Cmax [Time frame: 16 weeks]
- Tmax [Time frame: 16 weeks]
- t 1/2 [Time frame: 16 weeks]
- ADA [Time frame: 16 weeks]
Eligibility criteria
Inclusion criteria
- Healthy adult subjects
- Signed informed consent
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Friendship hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT07199270 · GR2303-001