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

Genrix (Shanghai) Biopharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Single Ascending Dose; Healthy Subjects

Treatments: Biological: GR2301 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07190716

GR2301-001

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 5 patient groups

GR2301 injection 1

Experimental group

Description:

GR2301 injection dose 1/Placebo，Subcutaneous

Treatment:

Biological: GR2301 injection

GR2301 injection 2

Experimental group

Description:

GR2301 injection dose 2/Placebo，Subcutaneous

Treatment:

Biological: GR2301 injection

GR2301 injection 3

Experimental group

Description:

GR2301 injection dose 3/Placebo，Subcutaneous

Treatment:

Biological: GR2301 injection

GR2301 injection 4

Experimental group

Description:

GR2301 injection dose 4/Placebo，Subcutaneous

Treatment:

Biological: GR2301 injection

GR2301 injection 5

Experimental group

Description:

GR2301 injection dose 5/Placebo，Subcutaneous

Treatment:

Biological: GR2301 injection