MedTrace Logo

Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum

NCT00448253 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-03-15

No results posted yet for this study

Summary

The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420 or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse events and laboratory assessments. To determine the dose proportionality relation of three different doses of NP-015.

Conditions

  • Symptoms of Inhalational Anthrax

Interventions

BIOLOGICAL

NP-015

Three Cohorts evaluating three dosage levels: 210, 420 or 840 units TNA, or placebo. And a Fourth Cohort at 840 units TNA with 2 additional product lots.

Sponsors & Collaborators

Principal Investigators

  • Alan S Marion, MD, PhD · MDS Pharma Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-08-31
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00448253 on ClinicalTrials.gov