Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-31 @ 7:28 AM
Study NCT ID:
NCT03046550
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety and PK of NTM-1634 vs Placebo Administered Intravenously in Healthy Adults
Sponsor:
Alachua Government Services, Inc.
Organization:
Study Overview
Official Title:
A Phase I, Double-Blind, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1634 vs Placebo Administered Intravenously in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2020-01
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 study evaluates the safety and pharmacokinetics of NTM-1634 in healthy subjects.
Detailed Description:
NTM-1634 drug product is a mixture of four human monoclonal IgG1 antibodies.
This study is a randomized, double-blind, placebo controlled dose escalation study of three dose cohorts. Cohort A: 0.33mg/kg; B: 0.66mg/kg; and C: 1 mg/kg.
This study is a randomized, double-blind, placebo controlled dose escalation study of three dose cohorts. Cohort A: 0.33mg/kg; B: 0.66mg/kg; and C: 1 mg/kg.
Study Oversight
Has Oversight DMC:
True
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 |
|---|---|---|---|---|
| 272201600009C-2-0-1 | NIH | None | https://reporter.nih.gov/quic… | View |