Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517914
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
A First-in-Human Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A First-in-Human Phase 1 Randomized Double-Blind Placebo-Controlled Single- and Multiple-Ascending Dose Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics Following Oral Administration of YH35995 in Healthy Adult Male Participants
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This is a randomized double-blind first-in-human study to assess the safety tolerability pharmacokinetics and pharmacodynamics of single and multiple oral doses of YH35995
Detailed Description:
YH35995 is being developed as a treatment for the neurological symptoms of Gaucher Disease type 3 This study is a first-in-human FIH phase 1 randomized double-blind placebo-controlled study of YH35995 which consists of two parts In Part A SAD single ascending dose of YH35995 is administered to healthy male participants to assess its safety tolerability PK and PD including an exploratory assessment of food effects In Part B MAD multiple ascending dose of YH35995 is administered to healthy male participants to assess its safety tolerability PK and PD
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