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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2026-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Single Ascending Dose Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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GR2301 injection 1

GR2301 injection dose 1/Placebo，Subcutaneous

Group Type EXPERIMENTAL

GR2301 injection

Intervention Type BIOLOGICAL

IL15 monoclonal antibody

GR2301 injection 2

GR2301 injection dose 2/Placebo，Subcutaneous

Group Type EXPERIMENTAL

GR2301 injection

Intervention Type BIOLOGICAL

IL15 monoclonal antibody

GR2301 injection 3

GR2301 injection dose 3/Placebo，Subcutaneous

Group Type EXPERIMENTAL

GR2301 injection

Intervention Type BIOLOGICAL

IL15 monoclonal antibody

GR2301 injection 4

GR2301 injection dose 4/Placebo，Subcutaneous

Group Type EXPERIMENTAL

GR2301 injection

Intervention Type BIOLOGICAL

IL15 monoclonal antibody

GR2301 injection 5

GR2301 injection dose 5/Placebo，Subcutaneous

Group Type EXPERIMENTAL

GR2301 injection

Intervention Type BIOLOGICAL

IL15 monoclonal antibody

Interventions

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GR2301 injection

IL15 monoclonal antibody

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes