NCT04923282

Recombinant Human Alkaline Phosphatase in Healthy Japanese Subjects

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: AM-Pharma · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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 N=6 on active and N=2 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 N=6 on active and N=2 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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	single 1-hour IV infusion of 0.8 mg/kg recAP	Intravenous infusion
BIOLOGICAL	single 1-hour IV infusion of 1.6 mg/kg recAP	Intravenous infusion
BIOLOGICAL	single 1-hour IV infusion of 3.2 mg/kg recAP	Intravenous infusion
BIOLOGICAL	1-hour infusions of 1.6 mg/kg recAP on Days 1, 2 and 3	Intravenous infusion
BIOLOGICAL	Placebo	Intravenous infusion

Timeline

• Start date: 2021-05-07
• Primary completion: 2021-07-08
• Completion: 2021-12-31
• First posted: 2021-06-11
• Last updated: 2022-03-14

Locations

1 site across 1 country: Japan