Clinical trial NCT06302374: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tetanus
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of AEs(Phase I)
timeFrame: Up to 105 days
measure: Tetanus-antibody titer(Phase II)
timeFrame: 24 hours post administration
Secondary outcomes:
measure: Tetanus-antibody titer(Phase I/II)
timeFrame: Up to 105 days
measure: Incidence of ADA(Phase I/II)
timeFrame: Up to 105 days
measure: Incidence of AEs(Phase II)
timeFrame: Up to 105 days
measure: Peak plasma concentration(Cmax)
timeFrame: Up to 105 days
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Up to 105 days
measure: Time of maximum plasma concentration (Tmax)
timeFrame: Up to 105 days
measure: Terminal half-life (T1/2)
timeFrame: Up to 105 days
measure: Apparent total body clearance (CL/F)
timeFrame: Up to 105 days
measure: Apparent volume of distribution (Vd/F)
timeFrame: Up to 105 days
measure: The elimination rate constant (Kel)
timeFrame: Up to 105 days
measure: Mean Residence Time (MRT)
timeFrame: Up to 105 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital affiliated of Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital affiliated of Fudan University
name: Jing Zhang, PHD
role: PRINCIPAL_INVESTIGATOR
References: