A Study to Evaluate the Safety of GR2301 Injection in Healthy Volunteers.
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: Single Ascending Dose, Healthy 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 Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Pharmacodynamic Characteristics of a Single Dose of GR2301 Injection in Healthy Adult Subjects in China.
Overview
This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary pharmacodynamic characteristics of GR2301 injection in healthy adult subjects in China.The GR2301 injection dosage will be gradually increased. All healthy subjects will receive a single subcutaneous injection. Following administration, subjects will be followed for at least 16 weeks ± 7 days.
Interventions
- Biological GR2301 injection
IL15 monoclonal antibody
Primary outcome measures
- Adverse events (AEs) [Time frame: up to week16]
Secondary outcome measures (2)
- Pharmacokinetics parameters [Time frame: up to week16]
- Incidence of ADA. [Time frame: up to week16]
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
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tongren Hospital Affiliated to Capital Medical University — Beijing
Identifiers
NCT: NCT07190716 · GR2301-001