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

Phase 1

Completed

• Conditions: Hematopoietic Syndrome Due to Acute Radiation Syndrome
• Interventions: Biological: HemaMax; Drug: Placebo

• Registration Number: NCT01742221
• Lead Sponsor: Neumedicines Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-06
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-14
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HemaMax	HemaMax	Single subcutaneous 12 microgram dose of HemaMax
Placebo	Placebo	Single subcutaneous dose

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of HemaMax in healthy subjects.	3 months	Number of subjects with adverse events as a measure of safety and tolerability

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetics, pharmacodynamics and immunogenicity of HemaMax in healthy subjects	3 months	To evaluate PK parameters AUC, Cmax, Tmax, t ½, Vz/F, and CL/F for HemaMax. To evaluate biological response parameters following HemaMax.

Trial Locations

Locations (1)

Covance Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States