Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313697
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-05
Brief Title:
A Study to Evaluate the Safety Immunogenicity and Pharmacokinetics of GR2102 in Healthy Adult
Sponsor:
Genrix Shanghai Biopharmaceutical Co Ltd
Organization:
Genrix Shanghai Biopharmaceutical Co Ltd
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
the goal this clinical trail is to evaluate the safetyPharmacokinetic 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 numberSubjects 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
After signing the informed consent form subjects who meet the criteria for enrollment will be entered into different groups according to the randomization numberSubjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None