Respiratory Syncytial Virus InfectionsPhase 1NCT06313697
A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2102 in Healthy Adult
A Phase 1 study testing GR2102 injection in people with Respiratory Syncytial Virus Infections, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
the goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- GR2102 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2024to 6 Dec 2025
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult subjects
- Signed informed consent
Who cannot join
- Signs and symptoms of upper respiratory tract infection prior to randomization
- Prior use of RSV vaccine or RSV antibody-based medications
- history of malignant tumor
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250102
linlin song, MD, 18853169334, qylcsyllwyh@163.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose Administration of GR2102 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2102
the goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be enrolled in only one of these groups。
Read the detailed description
This is a randomized, double-blind, placebo-controlled, single-dose administration study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2102 Injection in healthy adult Chinese subjects.
After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number.Subjects will be enrolled in only one of these groups.
Only after the 8 subjects in the current group have completed at least 7 days of safety and tolerability observations and have been determined to be safe and tolerable, will another group of subjects be allowed to proceed to the next group .
After completion of dosing, follow-up will be at least 150 days.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- GR2102 injection, placebo
- Keywords
- respiratory syncytial virus, RSV, respiratory infection
- Medical subject headings
- Respiratory Syncytial Virus Infections, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR2102 injectionBiological
single dose
placeboBiological
single dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | single dose Receives: Biological: GR2102 injection; Biological: placebo |
| Treatment group 2 | Experimental | single dose Receives: Biological: GR2102 injection; Biological: placebo |
| Treatment group 3 | Experimental | single dose Receives: Biological: GR2102 injection; Biological: placebo |
| Treatment group 4 | Experimental | single dose Receives: Biological: GR2102 injection; Biological: placebo |
| Treatment group 5 | Experimental | single dose Receives: Biological: GR2102 injection; Biological: placebo |
| Treatment group 6 | Experimental | single dose Receives: Biological: GR2102 injection; Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
to characterise the safety and tolerability of GR2102,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination
Measured: 150 days post dose
Secondary outcomes (3)
Maximum Observed Serum Concentration
Pharmacokinetic indices
Measured: 150 days post dose
Terminal Elimination Half Life
Pharmacokinetic indices
Measured: 150 days post dose
anti-respiratory syncytial virus neutralizing antibodies titer levels
indicator of immunogenicity
Measured: 150 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start23 Mar 2024
- Primary completion6 Jan 2025 (estimated)
- Study completion6 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- wei zhao, PHD, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313697
- Sponsor's protocol ID
- GR2102-001
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-dose Administration of GR2102 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2102
- ClinicalTrials.gov ID
- NCT06313697
- Acronym / sponsor ID
- GR2102-001
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- respiratory syncytial virus, RSV, respiratory infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2024 (actual)
- Primary completion
- 6 Jan 2025 (estimated)
- Study completion
- 6 Dec 2025 (estimated)
- First posted
- 15 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 goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be enrolled in only one of these groups。
Detailed description
This is a randomized, double-blind, placebo-controlled, single-dose administration study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2102 Injection in healthy adult Chinese subjects.
After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number.Subjects will be enrolled in only one of these groups.
Only after the 8 subjects in the current group have completed at least 7 days of safety and tolerability observations and have been determined to be safe and tolerable, will another group of subjects be allowed to proceed to the next group .
After completion of dosing, follow-up will be at least 150 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Biological: GR2102 injection, Biological: placebosingle dose |
| Treatment group 2 | Experimental | Biological: GR2102 injection, Biological: placebosingle dose |
| Treatment group 3 | Experimental | Biological: GR2102 injection, Biological: placebosingle dose |
| Treatment group 4 | Experimental | Biological: GR2102 injection, Biological: placebosingle dose |
| Treatment group 5 | Experimental | Biological: GR2102 injection, Biological: placebosingle dose |
| Treatment group 6 | Experimental | Biological: GR2102 injection, Biological: placebosingle dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult subjects
- Signed informed consent
Key exclusion criteria (3 listed)
- Signs and symptoms of upper respiratory tract infection prior to randomization
- Prior use of RSV vaccine or RSV antibody-based medications
- history of malignant tumor
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 |
|---|---|---|
| GR2102 injectionsingle dose | Biological | Treatment group 1, Treatment group 2, Treatment group 3, Treatment group 4, Treatment group 5, Treatment group 6 |
| placebosingle dose | Biological | Treatment group 1, Treatment group 2, Treatment group 3, Treatment group 4, Treatment group 5, Treatment group 6 |
Primary outcome
Adverse events
Time frame: 150 days post dose
to characterise the safety and tolerability of GR2102,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination
3 secondary outcomes
Maximum Observed Serum Concentration
Time frame: 150 days post dose
Terminal Elimination Half Life
Time frame: 150 days post dose
anti-respiratory syncytial virus neutralizing antibodies titer levels
Time frame: 150 days post dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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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.
wei zhao, PHD principal investigator
Shandong First Medical 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 study testing GR2102 injection in people with Respiratory Syncytial Virus Infections, 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Aug 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wei zhao, PHD (15131190710, zhao4wei@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 150 days post dose). 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 22 Aug 2024.