Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults
NCT ID: NCT06302374
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
202 participants
INTERVENTIONAL
2023-03-04
2024-02-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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Cohort 1 GR2001 0.01mg/kg/placebo
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).
GR2001
intramuscular injection
Placebo
intramuscular injection
Cohort 2 GR2001 0.02mg/kg/placebo
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).
GR2001
intramuscular injection
Placebo
intramuscular injection
Cohort 3 GR2001 0.05mg/kg/placebo/HTIG
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).
GR2001
intramuscular injection
Placebo
intramuscular injection
HTIG
intramuscular injection
Cohort 4 GR2001 0.1mg/kg/placebo
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).
GR2001
intramuscular injection
Placebo
intramuscular injection
Cohort 5 GR2001 0.2mg/kg/placebo
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).
GR2001
intramuscular injection
Placebo
intramuscular injection
Cohort 6 GR2001 0.1mg/kg/placebo
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.
GR2001
intramuscular injection
Placebo
intramuscular injection
Tetanus Toxoid
intramuscular injection
Cohort 7 GR2001 0.2mg/kg/placebo
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.
GR2001
intramuscular injection
Placebo
intramuscular injection
Tetanus Toxoid
intramuscular injection
Cohort 8 GR2001 0.1mg/kg/ GR2001 0.2mg/kg/ HTIG
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.
GR2001
intramuscular injection
HTIG
intramuscular injection
Tetanus Toxoid
intramuscular injection
Interventions
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GR2001
intramuscular injection
Placebo
intramuscular injection
HTIG
intramuscular injection
Tetanus Toxoid
intramuscular injection
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
ALL
Yes
Sponsors
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Genrix (Shanghai) Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jing Zhang, PHD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital affiliated of Fudan University
Locations
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Huashan Hospital affiliated of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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GR2001-001
Identifier Type: -
Identifier Source: org_study_id
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