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

November 14, 2018 updated by: Neumedicines Inc.

A Phase 1b, Single-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HemaMax™ (rHuIL-12) in Healthy Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Covance Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HemaMax
Single subcutaneous 12 microgram dose of HemaMax
Biological: HemaMax
single subcutaneous 12 microgram dose of HemaMax
Other Names:
  • rHuIL-12, NM-IL-12
PLACEBO_COMPARATOR: Placebo
Single subcutaneous dose
Drug: Placebo
single subcutaneous dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the safety and tolerability of HemaMax in healthy subjects.
Time Frame: 3 months
Number of subjects with adverse events as a measure of safety and tolerability
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To characterize the pharmacokinetics, pharmacodynamics and immunogenicity of HemaMax in healthy subjects
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neumedicines Inc.

Collaborators

Department of Health and Human Services

Investigators

  • Principal Investigator: Nicholas Siebers, MD, Covance Clinical Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

August 6, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (ESTIMATE)

December 5, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 14, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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