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Completed

NCT Number: NCT02343133

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

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.

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Key information

Conditions

Hematopoietic Syndrome Due to Acute Radiation Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Covance Clinical Research Unit, Daytona Beach, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HemaMax

Biological

Other names: rHuIL-12, NM-IL-12

Placebo

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. Pharmacokinetics of HemaMax (AUC, Cmax and Tmax)

    Time frame: 3 months

    PK parameters such as AUC, Cmax and Tmax as measures of pharmacokinetic exposure

  2. 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. Immunogenicity of HemaMax (Anti-drug antibodies as a measure of immunogenicity)

    Time frame: 3 months

    Anti-drug antibodies as a measure of immunogenicity

Sponsors and collaborators

Lead sponsor

Neumedicines Inc.

Industry

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 21, 2015
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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