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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: CDX-301
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1 Safety, Pharmacokinetic, and Immunologic Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers

Further study details as provided by Celldex Therapeutics:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDX-301
CDX-301 (rhuFlt3L), administered to healthy patients.
 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465139

Locations
United States, New York
Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Celldex Therapeutics
  More Information

No publications provided

Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT01465139     History of Changes
Other Study ID Numbers: CDX301-02
Study First Received: October 13, 2011
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 16, 2013