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A Single-dose, Dose-escalation Study of a Long-acting MOD-5014 in Healthy Adult Male

NCT02919800 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-09-30

No results posted yet for this study

Summary

A Phase 1, randomized, single-blind, placebo-controlled, single dose, dose-escalation study to assess the safety, pharmacokinetic and pharmacodynamic profile of subcutaneous administration of a long-acting recombinant factor VIIa (MOD-5014) in healthy adult males.

Conditions

  • Hemophilia A or B With Inhibitors

Interventions

BIOLOGICAL

MOD-5014

MOD-5014, a long-acting modified recombinant Factor VIIa

OTHER

MOD-5014 Placebo

Placebo solution for SC injection containing the same inactive ingredients used in the active drug product at matching volumes

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Ramit Arison · Associate Director Clinical Affairs OPKO Biologics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-22
Primary Completion
2018-02-21
Completion
2018-02-21

Countries

  • Israel

Study Locations

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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 NCT02919800 on ClinicalTrials.gov