Ignite Creation Date:
2024-05-06 @ 1:41 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01873885
Status:
COMPLETED
Last Update Posted:
2014-04-10
First Post:
2013-06-06
Brief Title:
Phase 1 Randomized Double-Blind Placebo-Controlled Exploratory Study That Will Assess the Safety Tolerability Pharmacokinetics and Hemodynamic Response to a Single 30 Minute Intravenous Infusion of Vasomera PB1046 in Adult Subjects With Stage 1 or 2 Essential Hypertension
Sponsor:
PhaseBio Pharmaceuticals Inc
Organization:
PhaseBio Pharmaceuticals Inc
Study Overview
Official Title:
Phase 1 Randomized Double-Blind Placebo-Controlled Exploratory Study That Will Assess the Safety Tolerability Pharmacokinetics and Hemodynamic Response to a Single 30 Minute Intravenous Infusion of Vasomera PB1046 in Adult Subjects With Stage 1 or 2 Essential Hypertension
Status:
COMPLETED
Status Verified Date:
2014-04
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:
This study is an exploratory Phase 1 randomized double-blind Investigator and study subject and 2-D echo endpoint assessor placebo-controlled single IV infusion dose escalation study that will enroll up to approximately 32 subjects with stage 1 or 2 essential hypertension
Detailed Description:
The study will be conducted in two parts
Part 1 For the initial evaluation of safety pharmacokinetic exposure and pharmacodynamic response subjects will be tapered off antihypertensive background therapyThe initial starting dose will be a sub-therapeutic dose Dose escalation will continue with a maximum of a doubling of the previous dose until either 1 a maximum tolerated dose MTD is identified or 2 modeling of the pharmacokinetic PK data indicate that maximum exposure Cmax at the next planned dose level would exceed a maximum drug concentration Cmax which was the maximum observed drug concentration following a single subcutaneous administration in Study PB1046-PT-CL-0001
Part 2 The dose group which is capable of providing a Cmax exposure which is capable of eliciting a clinically relevant hemodynamic response will be expanded to enroll an additional 12 subjects 6 active and 6 placebo
Part 1 For the initial evaluation of safety pharmacokinetic exposure and pharmacodynamic response subjects will be tapered off antihypertensive background therapyThe initial starting dose will be a sub-therapeutic dose Dose escalation will continue with a maximum of a doubling of the previous dose until either 1 a maximum tolerated dose MTD is identified or 2 modeling of the pharmacokinetic PK data indicate that maximum exposure Cmax at the next planned dose level would exceed a maximum drug concentration Cmax which was the maximum observed drug concentration following a single subcutaneous administration in Study PB1046-PT-CL-0001
Part 2 The dose group which is capable of providing a Cmax exposure which is capable of eliciting a clinically relevant hemodynamic response will be expanded to enroll an additional 12 subjects 6 active and 6 placebo
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