About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
GR2301 injection
DrugIL15 monoclonal antibody
Treatment groups
Trial outcomes
Primary outcomes
Adverse events (AEs)
Incidence of AEs
Secondary outcomes
Pharmacokinetics parameters
concentration of GR2301
Incidence of ADA.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: