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Completed

NCT Number: NCT01742221

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

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

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Key information

Conditions

Hematopoietic Syndrome Due to Acute Radiation Syndrome

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

About this study

A randomized, placebo-controlled, double-blind study of HemaMax to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of a single 12 μg subcutaneous dose of HemaMax on 60 healthy subjects for 28 days after HemaMax administration.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and Female subjects, who have signed the informed consent form must meet all of the following criteria
  • 18 to 45 years of age
  • Body mass index (BMI) > 19 and < 0 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)
  • Current 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

single subcutaneous 12 microgram dose of HemaMax

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

Placebo

Drug

single subcutaneous dose

Primary outcomes

  1. To determine the safety and tolerability of HemaMax in healthy subjects.

    Time frame: 3 months

    Number of subjects with adverse events as a measure of safety and tolerability

Secondary outcomes

  1. To characterize the pharmacokinetics, pharmacodynamics and immunogenicity of HemaMax in healthy subjects

    Time frame: 3 months

    To evaluate PK parameters AUC, Cmax, Tmax, t ½, Vz/F, and CL/F for HemaMax. To evaluate biological response parameters following HemaMax.

Sponsors and collaborators

Lead sponsor

Neumedicines Inc.

Industry

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

A Phase 1b, 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
2012
Primary completion
2012
Study completion
2012
First posted
Dec 5, 2012
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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