Recombinant Human Alkaline Phosphatase in Healthy Japanese Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

May 7, 2021

Primary Completion Date

July 8, 2021

Study Completion Date

December 31, 2021

Conditions
Healthy
Interventions
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

Trial Locations (1)

192-0071

P-One Clinic, Keikokai Medical Corporation, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AM-Pharma

INDUSTRY