Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults

Tetanus Clinical Trial

Official title:

A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 Injection in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06302374
• Other study ID #: GR2001-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 4, 2023
• Est. completion date: February 19, 2024

Study information

• Verified date: March 2024
• Source: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and Immunogenicity characteristics of GR2001 and compare the anti-tetanus neutralizing antibody titers of GR2001 with human tetanus immunoglobulin (HTIG)in healthy adult subjects.

Description:

This is a Multicentre, Randomized, Double-Blind, Placebo-Controlled, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 Injection in Healthy Subjects.

In the phase I part of the study, a total of 94 healthy subjects will be enrolled. The 94 healthy adult subjects will be enrolled into 7 cohorts sequentially. Each participant will receive a single IM dose of GR2001 or placebo or HTIG according to the cohort in which they were enrolled. After injection (Day 0), participants will remain in the study site for observation up to Day 1. The phase I part will last for 105 days following the assessments of safety, PK, PD and ADA.

In the phase II part of the study, a total of 108 healthy subjects will be enrolled. The 108 healthy subjects will be randomly assigned to the experimental group and the control group based on a ratio of 1:1:1:2:2:2.The phase II part will last for 105 days following the assessments of safety, PK, PD and ADA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 19, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Healthy male or female, 18-60 years of age (both inclusive);

2. Body mass index within 18.0-27.0 kg/m2 (both inclusive);

3. Subjects including partners are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last study drug administration.

4. Completed written informed consent process, signed the informed consent forms and Agreed to complete all follow-ups.

Exclusion Criteria:

1. History or evidence of severe drug or excipient allergy;

2. History or evidence of tetanus infection;

3. Inoculation of tetanus vaccine within 10 years;

4. History or evidence of any other acute or chronic disease;

5. Known or suspected history of drug abuse;

6. Positive outcome for Tetanus-antibody IgG test;

7. Nursing mothers or pregnant women.

Related Conditions & MeSH terms

• Tetanus

Intervention

Biological:
• GR2001
intramuscular injection
• Placebo
intramuscular injection
• HTIG
intramuscular injection
• Tetanus Toxoid
intramuscular injection

Locations

Country	Name	City	State
China	Huashan Hospital affiliated of Fudan University	Shanghai	Shanghai

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 AEs(Phase I)	Number of participants with treatment-related adverse events or serious adverse events.	Up to 105 days
Primary	Tetanus-antibody titer(Phase II)	Tetanus-antibody titer post administration.	24 hours post administration
Secondary	Tetanus-antibody titer(Phase I/II)	Tetanus-antibody titer post administration.	Up to 105 days
Secondary	Incidence of ADA(Phase I/II)	Incidence of ADA post administration.	Up to 105 days
Secondary	Incidence of AEs(Phase II)	Number of participants with treatment-related adverse events or serious adverse events.	Up to 105 days
Secondary	Peak plasma concentration(Cmax)	Estimated by non-compartmental analysis (NCA) with WinNonlin.	Up to 105 days
Secondary	Area under the plasma concentration versus time curve (AUC)	Estimated by non-compartmental analysis (NCA) with WinNonlin.	Up to 105 days
Secondary	Time of maximum plasma concentration (Tmax)	Estimated by non-compartmental analysis (NCA) with WinNonlin.	Up to 105 days
Secondary	Terminal half-life (T1/2)	Estimated by non-compartmental analysis (NCA) with WinNonlin.	Up to 105 days
Secondary	Apparent total body clearance (CL/F)	Estimated by non-compartmental analysis (NCA) with WinNonlin.	Up to 105 days
Secondary	Apparent volume of distribution (Vd/F)	Estimated by non-compartmental analysis (NCA) with WinNonlin.	Up to 105 days
Secondary	The elimination rate constant (Kel)	Estimated by non-compartmental analysis (NCA) with WinNonlin.	Up to 105 days
Secondary	Mean Residence Time (MRT)	Estimated by non-compartmental analysis (NCA) with WinNonlin.	Up to 105 days