A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics
ClinicalTrials.gov Identifier:
NCT01465139
First received: October 13, 2011
Last updated: January 7, 2013
Last verified: January 2013

October 13, 2011
January 7, 2013
October 2011
November 2012   (final data collection date for primary outcome measure)
Number of reported adverse events [ Time Frame: Until day 28 of follow up. ] [ Designated as safety issue: Yes ]
The number of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of CDX301.
Same as current
Complete list of historical versions of study NCT01465139 on ClinicalTrials.gov Archive Site
  • Determination of PK profile of CDX301 [ Time Frame: Until day 28 of follow up or until resolution. ] [ Designated as safety issue: Yes ]
    Levels of CDX301 in circulating blood will be evaluated by measures such as AUC, Cmax, T1/2, and Tmax
  • Immune system effects (eg: anti-CDX-301 antibody development, lymphoid cell populations, serum cytokines, and response to recall antigens and vaccination). [ Time Frame: Until day 28 of follow up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers
A Phase 1 Safety, Pharmacokinetic, and Immunologic Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers

CDX-301 is a protein that stimulates the growth of bone marrow stem cells and certain immune cells. This study is testing CDX-301 in healthy volunteers who will be monitored for safety and biological response for approximately one month or more.

A total of seven cohorts of healthy volunteers are planned with doses of CDX-301 (rhuFlt3L) ranging between 1 and 75 μg/kg and dosing durations between 5 and 10 days.

Volunteers will be admitted to an inpatient unit during the Treatment Period. Blood samples will be collected periodically to assess the effect of CDX-301. Volunteers will be followed for safety for 28 days following the last dose. Any volunteer who develops anti-CDX-301 antibodies will be followed monthly until the antibody response is below the limit of detection. In general, the total duration of the study will be between approximately 33-38 days.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy
Drug: CDX-301

CDX-301, administered in multiple dosages and frequencies depending on arm:

n=3-6 at between 1-75 μg/kg over 5 days

n=3-6 at 25 μg/kg over 7 days

n=3-6 at 25 μg/kg over 10 days

Experimental: CDX-301
CDX-301 (rhuFlt3L), administered to healthy patients.
Intervention: Drug: CDX-301
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2013
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Among other criteria, volunteers must meet the following conditions to be eligible for the study:

  1. Ages 18 - 55
  2. Body Weight ≤ 120 kg
  3. Generally good health and without significant medical conditions
  4. Willing to use effective method of contraception
  5. Abstinence from alcohol for 72 hours prior to study drug administration and throughout the study
  6. Negative screening test for HIV, hepatitis B, and hepatitis C
  7. Provide written informed consent

Exclusion Criteria:

Among other criteria, volunteers who meet the following conditions are NOT eligible for the study:

  1. Drug or alcohol abuse within 12 months
  2. Positive drug screen
  3. Receipt of certain types of experimental drugs or other treatments, or certain medications
  4. Use of systemic immunosuppressive agents (excluding topical steroids) within 12 months
  5. History of certain diseases including syphilis, herpes zoster, primary or secondary immunodeficiency
  6. Diagnosis with or family history of significant autoimmunity (ex: type I diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma)
  7. Any history of cancer, excluding adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ within 2 years
  8. History of asthma requiring any use of inhaled or oral medication within 5 years
  9. Herpes zoster within 3 months
  10. Donation of blood within 8 weeks, and donation of plasma within 2 weeks
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01465139
CDX301-02
No
Celldex Therapeutics
Celldex Therapeutics
Not Provided
Not Provided
Celldex Therapeutics
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP