TetanusPhase 1/2NCT06302374
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GR2001 in Chinese Healthy Adults
A Phase 1/2 study testing GR2001, HTIG and Tetanus Toxoid in people with Tetanus, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus
- What is being tested?
- GR2001, HTIG and Tetanus Toxoid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2023to 19 Feb 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital affiliated of Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
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
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.
Read the 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.
- Conditions
- Tetanus
- Being tested
- GR2001, Placebo, HTIG, Tetanus Toxoid
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR2001Biological
intramuscular injection
PlaceboBiological
intramuscular injection
HTIGBiological
intramuscular injection
Tetanus ToxoidBiological
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 GR2001 0.01mg/kg/placebo | Experimental | 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). Receives: Biological: GR2001; Biological: Placebo |
| Cohort 2 GR2001 0.02mg/kg/placebo | Experimental | 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). Receives: Biological: GR2001; Biological: Placebo |
| Cohort 3 GR2001 0.05mg/kg/placebo/HTIG | Experimental | 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). Receives: Biological: GR2001; Biological: Placebo; Biological: HTIG |
| Cohort 4 GR2001 0.1mg/kg/placebo | Experimental | 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). Receives: Biological: GR2001; Biological: Placebo |
| Cohort 5 GR2001 0.2mg/kg/placebo | Experimental | 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). Receives: Biological: GR2001; Biological: Placebo |
| Cohort 6 GR2001 0.1mg/kg/placebo | Experimental | 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. Receives: Biological: GR2001; Biological: Placebo; Biological: Tetanus Toxoid |
| Cohort 7 GR2001 0.2mg/kg/placebo | Experimental | 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. Receives: Biological: GR2001; Biological: Placebo; Biological: Tetanus Toxoid |
| Cohort 8 GR2001 0.1mg/kg/ GR2001 0.2mg/kg/ HTIG | Experimental | 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. Receives: Biological: GR2001; Biological: HTIG; Biological: Tetanus Toxoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs(Phase I)
Number of participants with treatment-related adverse events or serious adverse events.
Measured: Up to 105 days
Tetanus-antibody titer(Phase II)
Tetanus-antibody titer post administration.
Measured: 24 hours post administration
Secondary outcomes (11)
Tetanus-antibody titer(Phase I/II)
Tetanus-antibody titer post administration.
Measured: Up to 105 days
Incidence of ADA(Phase I/II)
Incidence of ADA post administration.
Measured: Up to 105 days
Incidence of AEs(Phase II)
Number of participants with treatment-related adverse events or serious adverse events.
Measured: Up to 105 days
Peak plasma concentration(Cmax)
Estimated by non-compartmental analysis (NCA) with WinNonlin.
Measured: Up to 105 days
Area under the plasma concentration versus time curve (AUC)
Estimated by non-compartmental analysis (NCA) with WinNonlin.
Measured: Up to 105 days
Time of maximum plasma concentration (Tmax)
Estimated by non-compartmental analysis (NCA) with WinNonlin.
Measured: Up to 105 days
Terminal half-life (T1/2)
Estimated by non-compartmental analysis (NCA) with WinNonlin.
Measured: Up to 105 days
Apparent total body clearance (CL/F)
Estimated by non-compartmental analysis (NCA) with WinNonlin.
Measured: Up to 105 days
Apparent volume of distribution (Vd/F)
Estimated by non-compartmental analysis (NCA) with WinNonlin.
Measured: Up to 105 days
The elimination rate constant (Kel)
Estimated by non-compartmental analysis (NCA) with WinNonlin.
Measured: Up to 105 days
Mean Residence Time (MRT)
Estimated by non-compartmental analysis (NCA) with WinNonlin.
Measured: Up to 105 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start4 Mar 2023
- Primary completion1 Nov 2023
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- More trials run by Genrix (Shanghai) Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, PHD, Principal investigator, Huashan Hospital affiliated of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302374
- Sponsor's protocol ID
- GR2001-001
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06302374
- Acronym / sponsor ID
- GR2001-001
- Conditions
- Tetanus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 GR2001 0.01mg/kg/placebo | Experimental | Biological: GR2001, Biological: PlaceboFour 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 | Experimental | Biological: GR2001, Biological: PlaceboTen 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 | Experimental | Biological: GR2001, Biological: Placebo, Biological: HTIG24 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 | Experimental | Biological: GR2001, Biological: PlaceboTen 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 | Experimental | Biological: GR2001, Biological: PlaceboTen 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 | Experimental | Biological: GR2001, Biological: Placebo, Biological: Tetanus ToxoidEighteen 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 | Experimental | Biological: GR2001, Biological: Placebo, Biological: Tetanus ToxoidEighteen 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 | Experimental | Biological: GR2001, Biological: HTIG, Biological: Tetanus ToxoidThirty 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GR2001intramuscular injection | Biological | Cohort 1 GR2001 0.01mg/kg/placebo, Cohort 2 GR2001 0.02mg/kg/placebo, Cohort 3 GR2001 0.05mg/kg/placebo/HTIG, Cohort 4 GR2001 0.1mg/kg/placebo, Cohort 5 GR2001 0.2mg/kg/placebo, Cohort 6 GR2001 0.1mg/kg/placebo, Cohort 7 GR2001 0.2mg/kg/placebo, Cohort 8 GR2001 0.1mg/kg/ GR2001 0.2mg/kg/ HTIG |
| Placebointramuscular injection | Biological | Cohort 1 GR2001 0.01mg/kg/placebo, Cohort 2 GR2001 0.02mg/kg/placebo, Cohort 3 GR2001 0.05mg/kg/placebo/HTIG, Cohort 4 GR2001 0.1mg/kg/placebo, Cohort 5 GR2001 0.2mg/kg/placebo, Cohort 6 GR2001 0.1mg/kg/placebo, Cohort 7 GR2001 0.2mg/kg/placebo |
| HTIGintramuscular injection | Biological | Cohort 3 GR2001 0.05mg/kg/placebo/HTIG, Cohort 8 GR2001 0.1mg/kg/ GR2001 0.2mg/kg/ HTIG |
| Tetanus Toxoidintramuscular injection | Biological | Cohort 6 GR2001 0.1mg/kg/placebo, Cohort 7 GR2001 0.2mg/kg/placebo, Cohort 8 GR2001 0.1mg/kg/ GR2001 0.2mg/kg/ HTIG |
Primary outcome
Incidence of AEs(Phase I)
Time frame: Up to 105 days
Number of participants with treatment-related adverse events or serious adverse events.
Tetanus-antibody titer(Phase II)
Time frame: 24 hours post administration
Tetanus-antibody titer post administration.
11 secondary outcomes
Tetanus-antibody titer(Phase I/II)
Time frame: Up to 105 days
Incidence of ADA(Phase I/II)
Time frame: Up to 105 days
Incidence of AEs(Phase II)
Time frame: Up to 105 days
Peak plasma concentration(Cmax)
Time frame: Up to 105 days
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 105 days
Time of maximum plasma concentration (Tmax)
Time frame: Up to 105 days
Terminal half-life (T1/2)
Time frame: Up to 105 days
Apparent total body clearance (CL/F)
Time frame: Up to 105 days
Apparent volume of distribution (Vd/F)
Time frame: Up to 105 days
The elimination rate constant (Kel)
Time frame: Up to 105 days
Mean Residence Time (MRT)
Time frame: Up to 105 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Zhang, PHD principal investigator
Huashan Hospital affiliated of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GR2001, HTIG and Tetanus Toxoid in people with Tetanus, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs(Phase I) (time frame: Up to 105 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.