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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954611
• Other study ID #: GR2002-001
• Status: Recruiting
• Phase: Phase 1
• Start date: June 16, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: July 2023
• Source: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Contact: Yi Fang, MD
• Phone: 010-66583834
• Email: fygk7000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• GR2002 injection
one single dose of GR2002 injection
• Placebo
one single dose of placebo

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AE)	Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing	85 days
Secondary	Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)	Time to reach peak concentration (Tmax)	85 days
Secondary	Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)	Peak Plasma concentration (Cmax)	85 days
Secondary	Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration	Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration	85 days
Secondary	Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)	Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)	85 days