Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649630
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
A Study Looking at How Different Doses of Study Medicine Inno8 Works in the Body of Healthy Men
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Oral Doses of Inno8 in Healthy Male Participants
Status:
RECRUITING
Status Verified Date:
2024-10
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:
VOYAGER1
Brief Summary:
This study will test how different doses of study medicine Inno8 work in the healthy men The purpose of this study is to prove safety of Inno8 in healthy men which will support further development of Inno8 in people with Haemophilia A The study is divided into two parts called the single ascending dose SAD part and multiple ascending dose MAD part and each part will have more than one cohort like sub-parts No matter which part the participants will be enrolled in they will either get the study medicine Inno8 or a dummy medicine that looks like the study medicine but has no effect on the body placebo Which treatment participants get is decided by chance The study medicine is a new medicine that cannot yet be prescribed by doctors In the SAD part participants will receive a single injection of study medicine or placebo and the study will last for up to 9 weeks In the MAD part participants will receive 1-2 tablets of study medicine or placebo daily for 10 days and the study will last for up to 11 weeks
Detailed Description:
None
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