Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558097
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Safety Tolerability and Pharmacokinetics of XXB750 in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A First-in-human Randomized Sponsor Open-label Participant and Investigator Blinded Placebo-controlled Single Ascending Dose Study to Explore the Safety Tolerability and Pharmacokinetics of XXB750 in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2024-08
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 study was a randomized participant and investigator-blinded placebo-controlled single-ascending dose study consisting of 9 sequential dose cohorts 1 mg 3 mg 10 mg 30 mg 60 mg 120 mg 240 mg 450 mg and 600 mg and a Japanese ethnic sensitivity cohort 240 mg dose
Detailed Description:
Eligible healthy participants with normal blood pressure SBP 110-139 mmHg DBP 70-89 mmHg were randomized into dose cohorts 1 - 240 mg Eligible healthy participants with elevated blood pressure SBP 139 - 159 mmHg DBP 75 - 95 mmHg were randomized into dose cohorts 450 and 600 mg Each participant received a subcutaneous single dose of either XXB750 or placebo In total the duration of the study was 151 days including the full Screening period of up to 28 days safety pharmacokinetics and pharmacodynamics assessments over a period of 91 days and a 30-day safety follow up call after the end of study visit
Sentinel dosing will be applied in this FIH study at each new dose level to ensure participants safety and minimize the number of participants that may experience symptomatic hypotension especially for sustained periods of time attributing to the long acting nature of XXB750 and the sustained pharmacological effects on BP at higher doses The 10-day safety monitoring for the sentinel cohort is considered sufficient based on the predicted mean Tmax 45 days in humans
Sentinel dosing will be applied in this FIH study at each new dose level to ensure participants safety and minimize the number of participants that may experience symptomatic hypotension especially for sustained periods of time attributing to the long acting nature of XXB750 and the sustained pharmacological effects on BP at higher doses The 10-day safety monitoring for the sentinel cohort is considered sufficient based on the predicted mean Tmax 45 days in humans
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