MedTrace Logo

Recombinant Human Alkaline Phosphatase in Healthy Japanese Subjects

NCT04923282 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-03-14

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • AM-Pharma

    lead INDUSTRY

Principal Investigators

  • Annelies Legters · AM-Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2021-07-08
Completion
2021-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04923282 on ClinicalTrials.gov