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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01742221
First Posted: December 5, 2012
Last Update Posted: April 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Neumedicines Inc.
  Purpose
This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of HemaMax in healthy male and female volunteers.

Condition Intervention Phase
Hematopoietic Syndrome Due to Acute Radiation Syndrome Biological: HemaMax Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Further study details as provided by Neumedicines Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HemaMax
Single subcutaneous dose of HemaMax
Biological: HemaMax
Placebo
Other Name: rHuIL-12
Placebo Comparator: Placebo
Single subcutaneous dose of Placebo
Biological: HemaMax
Placebo
Other Name: rHuIL-12

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

    1. 18 to 45 years of age
    2. Body mass index (BMI) > 19 and < 0 kg/m2
    3. Normal ECG, vital signs and laboratory test results
    4. Use of effective birth control method and abstinence from sex
    5. Negative pregnancy test and drug screen

Exclusion Criteria:

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

    1. History of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrine, urological, immunological, neurologic or psychiatric disorders or connective tissue disease
    2. Positive for human immunodeficiency virus (HIV), Hepatitis B, or surface antigen (HBsAg) or Hepatitis C antibody, tuberculosis (TB)
    3. Current drug or alcohol addiction
    4. History of clinically significant allergy of any kind
    5. Prior use of IL-12 or HemaMax
    6. Use of any approved or investigational biologic agents or vaccinations of any kind in last 3 months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742221


Locations
United States, Wisconsin
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Neumedicines Inc.
Department of Health and Human Services
Investigators
Principal Investigator: Nicholas Siebers, MD Covance Clinical Research Unit
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Neumedicines Inc.
ClinicalTrials.gov Identifier: NCT01742221     History of Changes
Other Study ID Numbers: 2012-002
First Submitted: August 6, 2012
First Posted: December 5, 2012
Last Update Posted: April 29, 2013
Last Verified: April 2013

Keywords provided by Neumedicines Inc.:
Safety and Tolerability, Cytokines, Acute Radiation Syndrome, Hematopoietic Syndrome, Radiation Countermeasure

Additional relevant MeSH terms:
Syndrome
Acute Radiation Syndrome
Radiation Injuries
Disease
Pathologic Processes
Wounds and Injuries