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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01742221

Enrollment

Registered

2012-12-05

Start date

2012-08-31

Completion date

2012-12-31

Last updated

2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Syndrome Due to Acute Radiation Syndrome

Keywords

HemaMax, NM-IL-12, HSARS, Safety

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.

Interventions

BIOLOGICALHemaMax

single subcutaneous 12 microgram dose of HemaMax

DRUGPlacebo

single subcutaneous dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026