Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04497662
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2020-07-28
Brief Title:
Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects
Sponsor:
Kiniksa Pharmaceuticals GmbH
Organization:
Kiniksa Pharmaceuticals GmbH
Study Overview
Official Title:
A Phase 1 First-in-human Randomized Double-blind Placebo-controlled Study Evaluating the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of KPL-404 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-05
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:
Phase 1 randomized double-blind placebo-controlled first-in-human study to investigate the safety tolerability PK and PD properties of single ascending intravenous IV and subcutaneous SC doses of KPL-404 in healthy subjects
Detailed Description:
This study includes 2 single ascending dose SAD parts Part A IV SAD up to 5 planned dose level cohorts and Part B SC SAD up to 3 planned dose level cohorts
Safety assessments will include adverse events AEs concomitant medications clinical laboratory vital signs 12-lead electrocardiogram and physical examination Serial blood samples for PK PD and anti-drug antibodies will be performed during each part of the study during the Treatment and Safety Evaluation Period
Safety assessments will include adverse events AEs concomitant medications clinical laboratory vital signs 12-lead electrocardiogram and physical examination Serial blood samples for PK PD and anti-drug antibodies will be performed during each part of the study during the Treatment and Safety Evaluation Period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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