Status:
NOT_YET_RECRUITING
A Study to Evaluate the Safety of GR2301 Injection in Healthy Volunteers.
Lead Sponsor:
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Conditions:
Single Ascending Dose
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary pharmacodynamic characteristics of ...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
October 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07190716
Start Date
October 10 2025
End Date
May 30 2026
Last Update
September 24 2025
Active Locations (1)
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1
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China