Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399315
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-05-01
Brief Title:
Study of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers
Sponsor:
Eilean Therapeutics
Organization:
Eilean Therapeutics
Study Overview
Official Title:
A Randomised Double-Blind Placebo-Controlled First-in-Human Study of the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-04
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 clinical study aiming to assess pharmacokinetics and biomarker evidence of ZE46-0134 efficacy in Healthy Volunteers after single and multiple daily doses of the study drug
Detailed Description:
This is a Phase 1 double-blind placebo-controlled dose escalation study to evaluate the safety tolerability PK PD of orally administered ZE46-0134 in Healthy Volunteers The study will be conducted in 2 parts a single ascending dose SAD part at up to 5 dose levels and a multiple ascending dose MAD part at up to 3 dose levels Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence Dosing in each cohort will start with two sentinel participants with one of the two sentinels randomised to receive ZE46-0134 and the other randomised to receive placebo The food-effect will be investigated in SAD part and safetyPK of co-administration with rabeprazole will be investigated in MAD part
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CT-2023-CTN-03208-1 | OTHER | therapeutic goods administration | None |