Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539507
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
A Study of the Safety Tolerability Pharmacokinetics and Immunogenicity of BCX17725
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 11b Study to Evaluate the Safety Tolerability Pharmacokinetics and Immunogenicity of Single and Multiple Ascending Doses of BCX17725 in Healthy Participants and Multiple Doses of BCX17725 in Participants With Netherton Syndrome
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a first-in-human Phase 11b 3-part study that includes the evaluation of safety tolerability pharmacokinetics PK and immunogenicity of BCX17725 when administered via single and multiple doses in healthy adult participants Parts 1 and 2 and multiple doses in participants with Netherton Syndrome Part 3
Detailed Description:
Parts 1 and 2 are randomized placebo-controlled single-ascending-dose SAD and multiple-ascending-dose MAD study parts respectively in healthy participants Part 3 will evaluate multiple dose administrations in participants with Netherton syndrome in an open-label design
Study Oversight
Has Oversight DMC:
None
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?:
None