Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546449
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
LH-001 Vs Placebo in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Double-Blind Placebo-Controlled Study Evaluating the Safety Tolerability and Pharmacokinetics of Single and Multiple Escalating Doses of LH-001 in Healthy Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to evaluate the safety and tolerability of LH-001 when administered as an oral single or multiple doses at ascending dose levels in healthy participants
Detailed Description:
This is a first-in-human randomized double-blinded placebo-controlled study This study consists of two parts 1 single ascending doses in 4 cohorts SAD and 2 14-day multiple ascending doses in 3 cohorts MAD Cohorts may be added or removed if needed due to safety considerations or deviations of actual PK parameters from predicted values
The SAD study consists of a screening visit a 2-day inpatient stay Day 1-2 a return visit for safety assessments on Day 3 and 4 and a follow-up by phone on Day 8
The MAD study consists of a screening visit a 2-day inpatient stay Day 1-2 daily return for dosing and safety assessments Day 3-13 a 2-day inpatient stay Day 14-15 and a follow-up by phone Day 21
The SAD study consists of a screening visit a 2-day inpatient stay Day 1-2 a return visit for safety assessments on Day 3 and 4 and a follow-up by phone on Day 8
The MAD study consists of a screening visit a 2-day inpatient stay Day 1-2 daily return for dosing and safety assessments Day 3-13 a 2-day inpatient stay Day 14-15 and a follow-up by phone Day 21
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None