Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-02-20 @ 6:33 PM
Study NCT ID:
NCT06049095
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2023-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants
Sponsor:
Latigo Biotherapeutics
Organization:
Study Overview
Official Title:
A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Male and Female Participants 18 to 55 Years of Age
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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 sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and multiple (MAD) ascending dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered LTG-001 in healthy male and female participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: