Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-29 @ 7:56 AM
Study NCT ID:
NCT02691702
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers
Sponsor:
Biogen
Organization:
Study Overview
Official Title:
A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo And Active Comparator Controlled, Dose Escalation Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Escalating Doses Of Pf-05251749 In Healthy Adult And Elderly Subjects
Status:
COMPLETED
Status Verified Date:
2021-02
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:
This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BIIB118
Detailed Description:
This study was previously posted by Pfizer. In March, 2020, sponsorship of the trial was transferred to Biogen.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MAD | OTHER | Alias Study Number | View |