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

A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Pharmacodynamic Characteristics of a Single Dose of GR2301 Injection in Healthy Adult Subjects in China.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07190716

Enrollment

Registered

2025-09-24

Start date

2025-10-10

Completion date

2026-05-30

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects, Single Ascending Dose

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.

Interventions

BIOLOGICALGR2301 injection

IL15 monoclonal antibody

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse events (AEs)	up to week16	Incidence of AEs

Secondary

Measure	Time frame	Description
Pharmacokinetics parameters	up to week16	concentration of GR2301
Incidence of ADA.	up to week16	—

Countries

China

Contacts

Primary Contactliaison officer

shuxueye@genrixbio.com18233161126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026