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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。
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Experimental | single dose |
|
| Treatment group 2 | Experimental | single dose |
|
| Treatment group 3 | Experimental | single dose |
|
| Treatment group 4 | Experimental | single dose |
|
| Treatment group 5 | Experimental | single dose |
|
| Treatment group 6 | Experimental | single dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR2102 injection | Biological | single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | to characterise the safety and tolerability of GR2102,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination | 150 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration | Pharmacokinetic indices | 150 days post dose |
| Terminal Elimination Half Life | Pharmacokinetic indices |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wei zhao, PHD | Contact | 15131190710 | zhao4wei@hotmail.com | |
| juan huang, MD | Contact | 19301494061 | huangjuan@genrixbio.com |
| Name | Affiliation | Role |
|---|---|---|
| wei zhao, PHD | Shandong First Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | 250102 | China |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| placebo | Biological | single dose |
|
| 150 days post dose |
| anti-respiratory syncytial virus neutralizing antibodies titer levels | indicator of immunogenicity | 150 days post dose |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |