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

Genrix (Shanghai) Biopharmaceutical Co., Ltd.202 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

202

Conditions

Tetanus

Interventions

GR2001BIOLOGICAL

intramuscular injection

PlaceboBIOLOGICAL

intramuscular injection

HTIGBIOLOGICAL

intramuscular injection

Tetanus Toxoid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Huashan Hospital affiliated of Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Incidence of AEs(Phase I)

Number of participants with treatment-related adverse events or serious adverse events.

Time frame: Up to 105 days

Tetanus-antibody titer(Phase II)

Tetanus-antibody titer post administration.

Time frame: 24 hours post administration

Secondary Outcomes

Tetanus-antibody titer(Phase I/II)

Tetanus-antibody titer post administration.

Time frame: Up to 105 days

Incidence of ADA(Phase I/II)

Incidence of ADA post administration.

Time frame: Up to 105 days

Incidence of AEs(Phase II)

Number of participants with treatment-related adverse events or serious adverse events.

Time frame: Up to 105 days

Peak plasma concentration(Cmax)

Estimated by non-compartmental analysis (NCA) with WinNonlin.

Time frame: Up to 105 days

Area under the plasma concentration versus time curve (AUC)

Estimated by non-compartmental analysis (NCA) with WinNonlin.

Time frame: Up to 105 days

Time of maximum plasma concentration (Tmax)

Estimated by non-compartmental analysis (NCA) with WinNonlin.

Time frame: Up to 105 days

Data from ClinicalTrials.gov

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