A Clinical Trial of Multiple Doses of GR2301 Injection in Healthy Adult Trial Participants in China.
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: GR2301 injection.
- Who it may be relevant to
- Registry conditions: Multiple Dose, Healthy Adult Participants. 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 →
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Official title
A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity Profiles of Multiple Doses of GR2301 Injection in Healthy Adult Trial Participants in China.
Overview
This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and immunogenicity characteristics of GR2301 injection in healthy adult subjects in China. The Multiple doses will be gradually escalated.
Interventions
- Drug GR2301 injection
IL15 monoclonal antibody
Primary outcome measures
- Adverse events (AEs) [Time frame: Up to 52 Weeks]
Secondary outcome measures (2)
- Pharmacokinetics parameters [Time frame: Up to 52 weeks]
- Incidence of ADA. [Time frame: Up to 52 weeks]
Eligibility criteria
Main Inclusion Criteria:
- BMI 19.0-28.0 kg/m², with male subjects weighing ≥50.0 kg and female subjects weighing ≥45.0 kg；
- Understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign the informed consent form.
Main Exclusion Criteria:
- A history of past or current conditions involving the nervous system, cardiovascular system, urinary system, digestive system, respiratory system, endocrine system, metabolic system, or other clearly documented medical conditions, which the investigator deems may pose a risk to the subject's safety or interfere with the conduct, progress, or completion of the trial.
- History of drug use or substance abuse, or positive urine drug screening prior to enrollment.
- Pregnant and breastfeeding women.
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
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tongren Hospital Affiliated to Capital Medical University — Beijing
Identifiers
NCT: NCT07647224 · GR2301-004