We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01742221
Previous Study | Return to List | Next Study

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

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.
ClinicalTrials.gov Identifier: NCT01742221
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : November 16, 2018
Department of Health and Human Services
Information provided by (Responsible Party):
Neumedicines Inc.

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

Condition or disease Intervention/treatment Phase
Hematopoietic Syndrome Due to Acute Radiation Syndrome Biological: HemaMax Drug: Placebo Phase 1

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : August 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: HemaMax
Single subcutaneous 12 microgram dose of HemaMax
Biological: HemaMax
single subcutaneous 12 microgram dose of HemaMax
Other Name: rHuIL-12, NM-IL-12

Placebo Comparator: Placebo
Single subcutaneous dose
Drug: Placebo
single subcutaneous dose

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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

Layout table for location information
United States, Wisconsin
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Neumedicines Inc.
Department of Health and Human Services
Layout table for investigator information
Principal Investigator: Nicholas Siebers, MD Covance Clinical Research Unit
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Neumedicines Inc.
ClinicalTrials.gov Identifier: NCT01742221    
Other Study ID Numbers: 2012-002
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Neumedicines Inc.:
HemaMax, NM-IL-12, HSARS, Safety
Additional relevant MeSH terms:
Layout table for MeSH terms
Radiation Injuries
Acute Radiation Syndrome
Wounds and Injuries