Safety Study of HemaMax™ (rHuIL-12) to Treat Acute Radiation Syndrome

Neumedicines

Status and phase: Completed; Phase 2

Conditions: Hematopoietic Syndrome Due to Acute Radiation Syndrome

Treatments: Biological: HemaMax; Drug: Placebo

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02343133

#HHSO100201100037C (Other Grant/Funding Number)

2014-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

HemaMax

Experimental group

Description:

Single subcutaneous 12 microgram dose of HemaMax

Treatment:

Biological: HemaMax

Placebo

Placebo Comparator group

Description:

Single subcutaneous dose

Treatment:

Drug: Placebo