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NCT Number: NCT07190716

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

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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Key information

Conditions

Single Ascending Dose Healthy Subjects

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Location contact

Assistant project manager

CONTACT

[email protected]

15811002557

chun Lai Lu, Ph.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • 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 Criteria:

  • 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.

Treatment and study plan

GR2301 injection

Biological

IL15 monoclonal antibody

Primary outcomes

  1. Adverse events (AEs)

    Time frame: up to week16

    Incidence of AEs

Secondary outcomes

  1. Pharmacokinetics parameters

    Time frame: up to week16

    concentration of GR2301

  2. Incidence of ADA.

    Time frame: up to week16

Study contacts

Contact information is provided by the study sponsor or research team.

liaison officer

CONTACT

[email protected]

18233161126

Sponsors and collaborators

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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