Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT05853835
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2023-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641
Sponsor:
LAPIX Therapeutics Inc.
Organization:
Study Overview
Official Title:
A Phase I First in Human, Randomized, Double-blind, Placebo- Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability and Pharmacokinetics of LPX-TI641 After Single and Multiple Oral Doses.
Status:
COMPLETED
Status Verified Date:
2024-06
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:
A Phase I First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single and Multiple Oral Dose of LPX-TI641.
Detailed Description:
This is a first-in-human, multi center, randomized, double-blinded, single and multiple ascending doses (SAD and MAD) Phase I study in healthy adult volunteers (HV).
The SAD cohorts will consist of six cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 48 HV). Additional cohorts may be added.
The MAD cohorts will consist of 3 cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 24 HV). The subjects in MAD cohorts will be dosed once daily for 7 consecutive days. Additional cohorts may be added.
Each entire cohort of 8 HV subjects will be enrolled at the same site.
The SAD cohorts will consist of six cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 48 HV). Additional cohorts may be added.
The MAD cohorts will consist of 3 cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 24 HV). The subjects in MAD cohorts will be dosed once daily for 7 consecutive days. Additional cohorts may be added.
Each entire cohort of 8 HV subjects will be enrolled at the same site.
Study Oversight
Has Oversight DMC:
False
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?: