Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525636
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-10
Brief Title:
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Open-label Phase 12 Dose-escalation and Subsequent Safety Extension Study of Subcutaneous KK8123 in Adult Patients With X-linked Hypophosphatemia
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:
A first-in-human study of KK8123 in adults with X-linked hypophosphatemia
Detailed Description:
Study 8123-001 is a Phase 12 multicenter open-label dose-escalation study to assess the safety tolerability PK and PD of KK8123 with an optional safety extension period This study is comprised of a Screening Period followed by Part 1 and Part 2 The Screening Period will last up to 28 days including obtaining informed consent Part 1 is a Dose Escalation Period consisting of a nominal planned Treatment Period all cohorts and Observation Period of 32 to 44 weeks and Part 2 is an optional Extension Period
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