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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Neumedicines Inc.
ClinicalTrials.gov Identifier:
NCT01742221
First received: August 6, 2012
Last updated: April 25, 2013
Last verified: April 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742221

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

No publications provided

Responsible Party: Neumedicines Inc.
ClinicalTrials.gov Identifier: NCT01742221     History of Changes
Other Study ID Numbers: 2012-002
Study First Received: August 6, 2012
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 21, 2014