Ignite Creation Date:
2024-05-06 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05318534
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2022-03-28
Brief Title:
Safety Tolerability Pharmacokinetic and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety Tolerability Pharmacokinetics and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease
Sponsor:
Gliknik Inc
Organization:
Gliknik Inc
Study Overview
Official Title:
GL-0719 - A Phase 1 Double-blind Placebo-controlled Single Ascending Intravenous and Subcutaneous Injection Dose Safety Tolerability Pharmacokinetic and Pharmacodynamic Study in Healthy Male and Female Subjects and an Open-label Evaluation of Safety Tolerability Pharmacokinetics and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this first-in-human FIH study is to evaluate the safety tolerability pharmacokinetics PK and pharmacodynamics PD of GL-0719 following single intravenous IV and subcutaneous injection SC doses in healthy adult male and female subjects
In addition safety tolerability PK and pilot efficacy biomarkers will be evaluated in subjects with cold agglutinin disease CAD
In addition safety tolerability PK and pilot efficacy biomarkers will be evaluated in subjects with cold agglutinin disease CAD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-004925-57 | EUDRACT_NUMBER | None | None |