The Study of Single Dose Administration of GR2002 Injection in Chinese Health Volunteers

• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05954611
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.5
• Patients Per Site Per Month: 9.1

Study Details

Study Description

Brief Summary

To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of GR2002 injection in Chinese healthy volunteers

Condition or Disease	Intervention/Treatment	Phase
Asthma	Biological: GR2002 injection; Biological: Placebo	Phase 1

Detailed Description

This is a randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity characteristics of single subcutaneous administration of GR2002 injection in healthy adult Chinese subjects.

The initial dose group is 35mg, and the subsequent doses will gradually increase. Only after all subjects in the current dose group have completed at least 2 weeks of safety and tolerance observation and confirmed safe tolerance, can they enter the next dose group for medication observation until the "dose increase termination standard" is reached.

Follow up will be conducted for at least 12 weeks ± 3 days after completion of medication administration.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase I, Randomized, Blinding, Single-dose, Placebo Control Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effect of GR2002 in Chinese Health Volunteers
• Actual Study Start Date: Jun 16, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GR2002 injection GR2002 subcutaneous injection	Biological: GR2002 injection; one single dose of GR2002 injection
Placebo Comparator: placebo placebo subcutaneous injection	Biological: Placebo; one single dose of placebo

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events (AE) [85 days]

   Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing

Secondary Outcome Measures

1. Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax) [85 days]

   Time to reach peak concentration (Tmax)

2. Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax) [85 days]

   Peak Plasma concentration (Cmax)

3. Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration [85 days]

   Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration

4. Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab) [85 days]

   Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 1. Age of 18 to 55 years, inclusive, male or female 2. BMI between 19 kg/m2 and 26 kg/m2 (inclusive) 3. Healthy volunteers

Exclusion Criteria:

• 1. History of chronic disease or serious disease 2. Subject with severe psychological or mental illness 3. Not enough washing-out period for previous therapy 4. Other.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing		China

Sponsors and Collaborators

• Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Yi Fang, MD, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05954611
• Other Study ID Numbers: GR2002-001
• First Posted: Jul 20, 2023
• Last Update Posted: Jul 20, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 20, 2023