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NCT07647224
A Clinical Trial of Multiple Doses of GR2301 Injection in Healthy Adult Trial Participants in China.
Conditions: Multiple Dose, Healthy Adult Participants
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 36
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Location: Beijing Tongren Hospital Affiliated to Capital Medical University Beijing Beijing Municipality
Summary
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
Main Inclusion Criteria:
1. BMI 19.0-28.0 kg/m², with male subjects weighing ≥50.0 kg and female subjects weighing ≥45.0 kg;
2. 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:
1. 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.
2. History of drug use or substance abuse, or positive urine drug screening prior to enrollment.
3. Pregnant and breastfeeding women.
Source: ClinicalTrials.gov (NCT07647224). StuddyBuddy aggregates publicly available trial information.