Safety Study of HemaMax™ (rHuIL-12) to Treat Acute Radiation Syndrome

November 14, 2018 updated by: Neumedicines Inc.

A Phase 2 Single-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HemaMax™ (rHuIL-12) in Healthy Subjects

The purpose of this study is to determine whether HemaMax is safe and well tolerated to support efficacy under FDA's Animal Rule to reduce the morbidity and mortality associated with the hematopoietic syndrome of acute radiation syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase 2 single dose, randomized, double-blind, placebo-controlled, multi center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HemaMax™ (rHuIL-12) in healthy adult male and female subjects considered representative of U.S. population.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Covance Clinical Research Unit
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Covance Clinical Research Unit
    • Texas
      • Dallas, Texas, United States, 75247
        • Covance Clinical Research Unit
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Covance Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male and Female healthy subjects who have signed the informed consent form must meet all of the following criteria

  • ≥18 to ≤75 years of age
  • Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2
  • Normal ECG, vital signs and laboratory test results
  • Use of effective birth control method and abstinence from sex
  • Negative pregnancy test and drug screen

Exclusion Criteria:

Subjects with any of the following characteristics will be considered ineligible:

  • History of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrine, urological, immunological, neurologic or psychiatric disorders or connective tissue disease
  • Positive for human immunodeficiency virus (HIV), Hepatitis B, or surface antigen (HBsAg) or Hepatitis C antibody, tuberculosis (TB)
  • Drug or alcohol addiction
  • History of clinically significant allergy of any kind
  • Prior use of IL-12 or HemaMax
  • Use of any approved or investigational biologic agents or vaccinations of any kind in last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HemaMax
Single subcutaneous 12 microgram dose of HemaMax
Biological: HemaMax
Other Names:
  • rHuIL-12, NM-IL-12
Placebo Comparator: Placebo
Single subcutaneous dose
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of HemaMax (Number of subjects with adverse events as a measure of safety and tolerability)
Time Frame: 3 months
Number of subjects with adverse events as a measure of safety and tolerability
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of HemaMax (AUC, Cmax and Tmax)
Time Frame: 3 months
PK parameters such as AUC, Cmax and Tmax as measures of pharmacokinetic exposure
3 months
Pharmacodynamics of HemaMax (IFN-g and CXCL-10 induction as a measure of pharmacodynamic response)
Time Frame: 3 months
IFN-g and CXCL-10 induction as a measure of pharmacodynamic response
3 months
Immunogenicity of HemaMax (Anti-drug antibodies as a measure of immunogenicity)
Time Frame: 3 months
Anti-drug antibodies as a measure of immunogenicity
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neumedicines Inc.

Collaborators

Department of Health and Human Services

Investigators

  • Principal Investigator: Nicholas Siebers, MD, Covance Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 20, 2015

First Posted (Estimate)

January 21, 2015

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 14, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-003
  • #HHSO100201100037C (Other Grant/Funding Number: BARDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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