Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04445038
Status:
UNKNOWN
Last Update Posted:
2021-01-28
First Post:
2020-06-21
Brief Title:
Safety Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Injection
Sponsor:
Sunshine Guojian Pharmaceutical Shanghai Co Ltd
Organization:
Sunshine Guojian Pharmaceutical Shanghai Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel Trial of Safety Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
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:
This study is Safety Tolerability and Pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody injection in Healthy Subjects There are 6 Groups as follows 003mgkg S1 02mgkg S2 10mgkg S3 30mgkg S4 50mgkg S5 and 75mgkg S6 and 2 subjects were included in the S1 group both received study drugs 10 subjects were included in each of the S2 S6 groups of which 8 received study drugs and 2 received placebo Pharmacokinetics and Anti-drug antibody ADA data will be collected Drug safety tolerance efficacy and immunogenicity for healthy subjects will be evaluated
Detailed Description:
This study is a randomized double-blind placebo-controlled parallel trial of safety tolerability and pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody by single subcutaneous injection with six different doses in healthy subjects There are 6 groups as follows 003mgkg S1 02mgkg S2 10mgkg S3 30mgkg S4 50mgkg S5 and 75mgkg S6 and 2 subjects were included in the S1 group both received study drugs 10 subjects were included in each of the S2 S6 groups of which 8 received study drugs and 2 received placebo In each group two subjects were sentinels 1 received the study drug and 1 placebo Pharmacokinetics and Anti-drug antibody ADA data will be collected Drug safety tolerance efficacy and immunogenicity for healthy subjects will be evaluated
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