Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults
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
1 other identifier
interventional
202
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2024
CompletedFirst Submitted
Initial submission to the registry
February 28, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedMarch 8, 2024
March 1, 2024
8 months
February 28, 2024
March 4, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of AEs(Phase I)
Number of participants with treatment-related adverse events or serious adverse events.
Up to 105 days
Tetanus-antibody titer(Phase II)
Tetanus-antibody titer post administration.
24 hours post administration
Secondary Outcomes (11)
Tetanus-antibody titer(Phase I/II)
Up to 105 days
Incidence of ADA(Phase I/II)
Up to 105 days
Incidence of AEs(Phase II)
Up to 105 days
Peak plasma concentration(Cmax)
Up to 105 days
Area under the plasma concentration versus time curve (AUC)
Up to 105 days
- +6 more secondary outcomes
Study Arms (8)
Cohort 1 GR2001 0.01mg/kg/placebo
EXPERIMENTALFour 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).
Cohort 2 GR2001 0.02mg/kg/placebo
EXPERIMENTALTen 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).
Cohort 3 GR2001 0.05mg/kg/placebo/HTIG
EXPERIMENTAL24 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).
Cohort 4 GR2001 0.1mg/kg/placebo
EXPERIMENTALTen 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).
Cohort 5 GR2001 0.2mg/kg/placebo
EXPERIMENTALTen 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).
Cohort 6 GR2001 0.1mg/kg/placebo
EXPERIMENTALEighteen 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.
Cohort 7 GR2001 0.2mg/kg/placebo
EXPERIMENTALEighteen 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.
Cohort 8 GR2001 0.1mg/kg/ GR2001 0.2mg/kg/ HTIG
EXPERIMENTALThirty 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.
Interventions
intramuscular injection
intramuscular injection
intramuscular injection
intramuscular injection
Eligibility Criteria
You may qualify if:
- Healthy male or female, 18-60 years of age (both inclusive);
- Body mass index within 18.0-27.0 kg/m2 (both inclusive);
- Subjects including partners are willing to voluntarily take effective contraceptive measures from screening to 6 months after the last study drug administration.
- Completed written informed consent process, signed the informed consent forms and Agreed to complete all follow-ups.
You may not qualify if:
- History or evidence of severe drug or excipient allergy;
- History or evidence of tetanus infection;
- Inoculation of tetanus vaccine within 10 years;
- History or evidence of any other acute or chronic disease；
- Known or suspected history of drug abuse；
- Positive outcome for Tetanus-antibody IgG test;
- Nursing mothers or pregnant women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Huashan Hospital affiliated of Fudan University
Shanghai, Shanghai Municipality, 200040, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing Zhang, PHD
Huashan Hospital affiliated of Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2024
First Posted
March 8, 2024
Study Start
March 4, 2023
Primary Completion
November 1, 2023
Study Completion
February 19, 2024
Last Updated
March 8, 2024
Record last verified: 2024-03