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

Neumedicines

Status and phase

Completed

Phase 1

Conditions

Hematopoietic Syndrome Due to Acute Radiation Syndrome

Treatments

Drug: Placebo

Biological: HemaMax

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT01742221

2012-002

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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