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Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure

NCT01742221 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-11-16

No results posted yet for this study

Summary

This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of HemaMax in healthy male and female volunteers.

Conditions

  • Hematopoietic Syndrome Due to Acute Radiation Syndrome

Interventions

BIOLOGICAL

HemaMax

single subcutaneous 12 microgram dose of HemaMax

DRUG

Placebo

single subcutaneous dose

Sponsors & Collaborators

Principal Investigators

  • Nicholas Siebers, MD · Covance Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01742221 on ClinicalTrials.gov