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

Neumedicines Inc.60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hematopoietic Syndrome Due to Acute Radiation Syndrome

Interventions

HemaMaxBIOLOGICAL

single subcutaneous 12 microgram dose of HemaMax

PlaceboDRUG

single subcutaneous dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Covance Clinical Research Unit

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

To determine the safety and tolerability of HemaMax in healthy subjects.

Number of subjects with adverse events as a measure of safety and tolerability

Time frame: 3 months

Secondary Outcomes

To characterize the pharmacokinetics, pharmacodynamics and immunogenicity of HemaMax in healthy subjects

To evaluate PK parameters AUC, Cmax, Tmax, t ½, Vz/F, and CL/F for HemaMax. To evaluate biological response parameters following HemaMax.

Time frame: 3 months

Data from ClinicalTrials.gov

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