Ignite Creation Date:
2024-05-06 @ 2:36 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04367441
Status:
UNKNOWN
Last Update Posted:
2020-04-29
First Post:
2020-04-25
Brief Title:
Randomized Double Blinded Placebo Controlled Single Dose Escalation Study of 608 in Healthy Subjects
Sponsor:
Sunshine Guojian Pharmaceutical Shanghai Co Ltd
Organization:
Sunshine Guojian Pharmaceutical Shanghai Co Ltd
Study Overview
Official Title:
A Study of Single Dose Escalation Randomized Double Blinded Placebo Controlled to Investigate the Tolerability Safety Profiles Pharmacokinetic of Recombinant Humanized Anti-IL17A Monoclonal Antibody Injection in Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2020-04
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 is a first-in-human phase 1 single-center randomized double blinded placebo-controlled single dose-escalation study to evaluate the safety tolerability PK of 608 following subcutaneous injection in healthy subjects
Detailed Description:
The study will consist of a 14-days screening period -14-1 days an observation period 7-14 days and the follow-up period 71-91days Subjects will be randomly assigned to seven group
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