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

Neumedicines Inc.200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Hematopoietic Syndrome Due to Acute Radiation Syndrome

Interventions

HemaMaxBIOLOGICAL

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Covance Clinical Research Unit

Daytona Beach, Florida, United States

Covance Clinical Research Unit

Evansville, Indiana, United States

Covance Clinical Research Unit

Dallas, Texas, United States

Covance Clinical Research Unit

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Safety and tolerability of HemaMax (Number of subjects with adverse events as a measure of safety and tolerability)

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

Time frame: 3 months

Secondary Outcomes

Pharmacokinetics of HemaMax (AUC, Cmax and Tmax)

PK parameters such as AUC, Cmax and Tmax as measures of pharmacokinetic exposure

Time frame: 3 months

Pharmacodynamics of HemaMax (IFN-g and CXCL-10 induction as a measure of pharmacodynamic response)

IFN-g and CXCL-10 induction as a measure of pharmacodynamic response

Time frame: 3 months

Immunogenicity of HemaMax (Anti-drug antibodies as a measure of immunogenicity)

Anti-drug antibodies as a measure of immunogenicity

Time frame: 3 months

Data from ClinicalTrials.gov

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