Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2025-12-24 @ 4:33 PM
Study NCT ID:
NCT02083666
Status:
TERMINATED
Last Update Posted:
2015-07-28
First Post:
2014-01-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration
Sponsor:
Swedish Orphan Biovitrum
Organization:
Study Overview
Official Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SOBI002 Following Subcutaneous and Intravenous Administration. A Double-blind, Placebo-controlled, Randomized Within Dose Cohort, Single and Repeated Dose-escalation Study in Healthy Volunteers
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Transient adverse events observed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.
Detailed Description:
This is a double-blind, placebo-controlled, randomized within dose cohort single and repeated dose study with sequential dose escalation.
Eligible volunteers will be divided into dose cohorts and for each cohort, a new panel of 8 volunteers will be randomized to receive either SOBI002 (n=6) or placebo (n=2). SOBI002 will either be administered subcutaneously or intravenously.
Eligible volunteers will be divided into dose cohorts and for each cohort, a new panel of 8 volunteers will be randomized to receive either SOBI002 (n=6) or placebo (n=2). SOBI002 will either be administered subcutaneously or intravenously.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: