Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853835
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-04-28
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:
LAPIX Therapeutics Inc
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:
RECRUITING
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:
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