Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592131
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
BF844 Safety and Pharmacokinetic Study in Healthy Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
First-in-Human Phase-1 Randomised Double-Blinded Placebo Controlled Study to Assess Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses As Well As a Food Effect Study of BF844 When Administered Orally to Healthy Adult Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
First-in-Human Phase-1 Clinical Trial to Assess Safety Tolerability Pharmacokinetics Pharmacodynamics and Food Effect of Single and Multiple Ascending Doses of BF844 when Administered Orally to Healthy Adult Participants
Detailed Description:
This is a first-in-human single center randomized double-blinded single and multiple ascending doses SAD and MAD and food effect Phase I study in healthy adult volunteers HV
The SAD cohorts will consist of five cohorts of eight participants 6 randomized to treatment 2 randomized to placebo in each cohort Total 40 HV Additional cohorts may be added
The food effect FE cohort will consist of 12 participants who receive a single dose of BF844 in a cross-over manner Each participants will receive the same single dose of BF844 under two separate conditions one after an overnight fast and the second following a high-fat breakfast 30 minutes prior to dosing
The MAD cohorts will consist of 3 cohorts of eight participants 6 randomized to treatment 2 randomized to placebo in each cohort Total 24 HV The subjects in MAD cohorts will be dosed once daily for 7 consecutive days Additional cohorts may be added
For each cohort all HV subjects will be enrolled at the same site To optimise participants safety BF844 will be administered in a staggered manner as per protocol
The SAD cohorts will consist of five cohorts of eight participants 6 randomized to treatment 2 randomized to placebo in each cohort Total 40 HV Additional cohorts may be added
The food effect FE cohort will consist of 12 participants who receive a single dose of BF844 in a cross-over manner Each participants will receive the same single dose of BF844 under two separate conditions one after an overnight fast and the second following a high-fat breakfast 30 minutes prior to dosing
The MAD cohorts will consist of 3 cohorts of eight participants 6 randomized to treatment 2 randomized to placebo in each cohort Total 24 HV The subjects in MAD cohorts will be dosed once daily for 7 consecutive days Additional cohorts may be added
For each cohort all HV subjects will be enrolled at the same site To optimise participants safety BF844 will be administered in a staggered manner as per protocol
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