Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure
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ClinicalTrials.gov Identifier: NCT01742221 |
Recruitment Status :
Completed
First Posted : December 5, 2012
Last Update Posted : November 16, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hematopoietic Syndrome Due to Acute Radiation Syndrome | Biological: HemaMax Drug: Placebo | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: HemaMax
Single subcutaneous 12 microgram dose of HemaMax
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Biological: HemaMax
single subcutaneous 12 microgram dose of HemaMax
Other Name: rHuIL-12, NM-IL-12 |
Placebo Comparator: Placebo
Single subcutaneous dose
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Drug: Placebo
single subcutaneous dose |
- 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
- 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.

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

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
United States, Wisconsin | |
Covance Clinical Research Unit | |
Madison, Wisconsin, United States, 53704 |
Principal Investigator: | Nicholas Siebers, MD | Covance Clinical Research Unit |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
HemaMax, NM-IL-12, HSARS, Safety |
Radiation Injuries Acute Radiation Syndrome Wounds and Injuries |