Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363383
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-29
Brief Title:
A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants
Sponsor:
Mage Biologics
Organization:
Mage Biologics
Study Overview
Official Title:
A Double-blind Placebo-controlled Phase 1 Study to Evaluate the Safety and Efficacy of MB-001 in Single and Multiple Ascending Doses in Healthy Human Participants
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:
The goal of this clinical trial is to learn if the oral biologic MB-001 is safe in healthy volunteers The main questions it aims to answer are
Is the drug safe when administered orally at increasing doses Researchers will compare the drug with placebo to see if there are more side effects in those receiving the drug
Participants will receive a single or five daily doses of the drug or placebo and will be asked to stay in the clinic for five days following the last dose
Is the drug safe when administered orally at increasing doses Researchers will compare the drug with placebo to see if there are more side effects in those receiving the drug
Participants will receive a single or five daily doses of the drug or placebo and will be asked to stay in the clinic for five days following the last dose
Detailed Description:
This is a two-stage single-center double-blinded randomized placebo-controlled study evaluating the safety ofMB-001 in healthy adult participants
The two stages are
A single ascending dose SAD stage in healthy participants
A multiple ascending dose MAD stage in healthy participants
Up to 5 cohorts of healthy adult participants will receive a single oral dose of either MB-001 or placebo Following a review of all safety data available for the current cohort and any preceding cohorts the Safety Review Committee SRC will decide whether to proceed to the next cohort The MAD stage in healthy participants will commence once sufficient safety data are available from the SAD stage after the completion of all SAD cohorts
The two stages are
A single ascending dose SAD stage in healthy participants
A multiple ascending dose MAD stage in healthy participants
Up to 5 cohorts of healthy adult participants will receive a single oral dose of either MB-001 or placebo Following a review of all safety data available for the current cohort and any preceding cohorts the Safety Review Committee SRC will decide whether to proceed to the next cohort The MAD stage in healthy participants will commence once sufficient safety data are available from the SAD stage after the completion of all SAD cohorts
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