Viewing Study NCT05853835



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

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