A Study to Evaluate the Safety of GR2301 Injection in Healthy Volunteers.

Not Applicable

Not yet recruiting

• Conditions: Single Ascending Dose; Healthy Subjects
• Interventions: Biological: GR2301 injection

• Registration Number: NCT07190716
• Lead Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Study Start: 2025-10-10
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GR2301 injection 1	GR2301 injection	GR2301 injection dose 1/Placebo，Subcutaneous
GR2301 injection 2	GR2301 injection	GR2301 injection dose 2/Placebo，Subcutaneous
GR2301 injection 5	GR2301 injection	GR2301 injection dose 5/Placebo，Subcutaneous
GR2301 injection 3	GR2301 injection	GR2301 injection dose 3/Placebo，Subcutaneous
GR2301 injection 4	GR2301 injection	GR2301 injection dose 4/Placebo，Subcutaneous

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	up to week16	Incidence of AEs

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters	up to week16	concentration of GR2301
Incidence of ADA.	up to week16

Trial Locations

Locations (1)

Beijing Tongren Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China