Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05549219
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2022-08-24
Brief Title:
24-Week Study to Assess the PD Safety Tolerability and PK of GLM101 in Participants With PMM2-CDG
Sponsor:
Glycomine Inc
Organization:
Glycomine Inc
Study Overview
Official Title:
A Phase 2 Randomized Open-Label 24-Week Study to Assess the Pharmacodynamics Safety Tolerability and Pharmacokinetics of Multiple Doses of GLM101 Administered Intravenously to Adult Adolescent and Pediatric Participants With PMM2-CDG
Status:
RECRUITING
Status Verified Date:
2024-03
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 a Phase 2 randomized open-label 24-week treatment study to evaluate the potential pharmacodynamic PD activity safety tolerability and pharmacokinetics PK of GLM101 in adult adolescent and pediatric patients with a confirmed diagnosis of PMM2-CDG The planned doses of GLM101 to be investigated are 10 20 and 30 mgkg The study will consist of a Screening Period a 24-week 6-month Treatment Period and a 30-day 1-month Follow-Up Period
Detailed Description:
None
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