Hematopoietic Syndrome Due to Acute Radiation Syndrome
Conditions
Keywords
HemaMax, NM-IL-12, HSARS, Safety
Brief summary
The purpose of this study is to determine whether HemaMax is safe and well tolerated to support efficacy under FDA's Animal Rule to reduce the morbidity and mortality associated with the hematopoietic syndrome of acute radiation syndrome.
Detailed description
This is a phase 2 single dose, randomized, double-blind, placebo-controlled, multi center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HemaMax™ (rHuIL-12) in healthy adult male and female subjects considered representative of U.S. population.
Interventions
BIOLOGICALHemaMax
DRUGPlacebo
Sponsors
Department of Health and Human Services
Neumedicines Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Male and Female healthy subjects who have signed the informed consent form must meet all of the following criteria * ≥18 to ≤75 years of age * Body mass index (BMI) ≥ 18 and ≤ 35 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of HemaMax (Number of subjects with adverse events as a measure of safety and tolerability) | 3 months | Number of subjects with adverse events as a measure of safety and tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of HemaMax (AUC, Cmax and Tmax) | 3 months | PK parameters such as AUC, Cmax and Tmax as measures of pharmacokinetic exposure |
| Pharmacodynamics of HemaMax (IFN-g and CXCL-10 induction as a measure of pharmacodynamic response) | 3 months | IFN-g and CXCL-10 induction as a measure of pharmacodynamic response |
| Immunogenicity of HemaMax (Anti-drug antibodies as a measure of immunogenicity) | 3 months | Anti-drug antibodies as a measure of immunogenicity |
Countries
United States
Outcome results
None listed