Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923282
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2021-05-25
Brief Title:
Recombinant Human Alkaline Phosphatase in Healthy Japanese Subjects
Sponsor:
AM-Pharma
Organization:
AM-Pharma
Study Overview
Official Title:
A Double Blind Randomized Single Center Single and Multiple Dose Pharmacokinetic Safety and Tolerability Study of Recombinant Human Alkaline Phosphatase recAP Administered Intravenously in Healthy Japanese Subjects
Status:
COMPLETED
Status Verified Date:
2022-03
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:
Clinical Phase 1 study to investigate the pharmacokinetics and to assess the safety and tolerability of recAP after single and multiple intravenous doses in healthy Japanese subjects
Detailed Description:
This study is a randomized double blind parallel group single-center trial consisting of a single dose part and a multiple dose part in 32 healthy Japanese subjects Since all these doses have been studied before and safety extensively evaluated in non-Japanese subjects and no ethnic sensitivity is expected the groups can be dosed in parallel
Part A will have 3 parallel groups of 8 male subjects with N6 on active and N2 on placebo per group Following baseline assessments a single dose of recAP will be administered by a one-hour infusion followed by samplings for pharmacokinetic evaluation and routine safety assessments
Part B will have a single group of 8 male subjects with N6 on active and N2 on placebo Following baseline assessments recAP will be dosed on Days 1 2 and 3 by one-hour infusions followed by samplings for pharmacokinetic evaluation and routine safety assessments
Part A will have 3 parallel groups of 8 male subjects with N6 on active and N2 on placebo per group Following baseline assessments a single dose of recAP will be administered by a one-hour infusion followed by samplings for pharmacokinetic evaluation and routine safety assessments
Part B will have a single group of 8 male subjects with N6 on active and N2 on placebo Following baseline assessments recAP will be dosed on Days 1 2 and 3 by one-hour infusions followed by samplings for pharmacokinetic evaluation and routine safety assessments
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