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

Genrix (Shanghai) Biopharmaceutical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Tetanus

Treatments: Biological: GR2001; Biological: Tetanus Toxoid; Biological: Placebo; Biological: HTIG

Study type: Interventional

Funder types: Industry

Identifiers

NCT06302374

GR2001-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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202 participants in 8 patient groups

Cohort 1 GR2001 0.01mg/kg/placebo

Experimental group

Description:

Four subjects will be randomly assigned to receive either GR2001 or placebo at a 3:1 ratio (i.e. 3 subjects receive GR2001 and 1 with placebo).

Treatment:

Biological: GR2001

Biological: Placebo

Cohort 2 GR2001 0.02mg/kg/placebo

Experimental group

Description:

Ten subjects will be randomly assigned to receive either GR2001 or placebo at a 4:1 ratio (i.e. 8 subjects receive GR2001 and 2 with placebo).

Treatment:

Biological: GR2001

Biological: Placebo

Cohort 3 GR2001 0.05mg/kg/placebo/HTIG

Experimental group

Description:

24 subjects will be randomly assigned to receive GR2001 or placebo or HTIG(250IU) at a 1:1:1 ratio (i.e. 8 subjects receive GR2001, 8 with placebo and 8 with HTIG).

Treatment:

Biological: GR2001

Biological: HTIG

Biological: Placebo

Cohort 4 GR2001 0.1mg/kg/placebo

Experimental group

Description:

Ten subjects will be randomly assigned to receive either GR2001 or placebo at a 4:1 ratio (i.e. 8 subjects receive GR2001 and 2 with placebo).

Treatment:

Biological: GR2001

Biological: Placebo

Cohort 5 GR2001 0.2mg/kg/placebo

Experimental group

Description:

Ten subjects will be randomly assigned to receive either GR2001 or placebo at a 4:1 ratio (i.e. 8 subjects receive GR2001 and 2 with placebo).

Treatment:

Biological: GR2001

Biological: Placebo

Cohort 6 GR2001 0.1mg/kg/placebo

Experimental group

Description:

Eighteen subjects will be randomly assigned to receive either GR2001 or placebo at a 2:1 ratio (i.e. 12 subjects receive GR2001 and 6 with placebo) followed by a dose of Tetanus Toxoid（TT） on Day0.

Treatment:

Biological: Tetanus Toxoid

Biological: GR2001

Biological: Placebo

Cohort 7 GR2001 0.2mg/kg/placebo

Experimental group

Description:

Eighteen subjects will be randomly assigned to receive either GR2001 or placebo at a 2:1 ratio (i.e. 12 subjects receive GR2001 and 6 with placebo) followed by a dose of Tetanus Toxoid（TT） on Day0.

Treatment:

Biological: Tetanus Toxoid

Biological: GR2001

Biological: Placebo

Cohort 8 GR2001 0.1mg/kg/ GR2001 0.2mg/kg/ HTIG

Experimental group

Description:

Thirty six subjects will be randomly assigned to receive GR2001(0.1mg/kg) or GR2001(0.2mg/kg) or HTIG(250IU) at a 1:1:1 ratio (i.e. 12 subjects receive GR2001(0.1mg/kg), 12 with GR2001(0.2mg/kg) and 12 with HTIG). Seventy two subjects will be randomly assigned to receive GR2001(0.1mg/kg) or GR2001(0.2mg/kg) or HTIG(250IU) at a 1:1:1 ratio (i.e. 24 subjects receive GR2001(0.1mg/kg), 24 with GR2001(0.2mg/kg) and 24 with HTIG) followed by one dose of Tetanus Toxoid（TT） on Day0 and Day28.

Treatment:

Biological: Tetanus Toxoid

Biological: GR2001

Biological: HTIG