A Clinical Trial of Multiple Doses of GR2301 Injection in Healthy Adult Trial Participants in China.

A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity Profiles of Multiple Doses of GR2301 Injection in Healthy Adult Trial Participants in China.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07647224

Enrollment

Registered

2026-06-15

Start date

2026-06-01

Completion date

2027-07-01

Last updated

2026-06-15

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

Conditions

Healthy Adult Participants, Multiple Dose

Keywords

IL15

Brief summary

This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and immunogenicity characteristics of GR2301 injection in healthy adult subjects in China. The Multiple doses will be gradually escalated.

Interventions

DRUGGR2301 injection

IL15 monoclonal antibody

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, 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 52 Weeks	Incidence of AEs

Secondary

Measure	Time frame	Description
Pharmacokinetics parameters	Up to 52 weeks	concentration of GR2301
Incidence of ADA.	Up to 52 weeks	—

Countries

China

Contacts

CONTACTliaison officer

shuxueye@genrixbio.com021-50805988-8039

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026