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Completed

NCT Number: NCT01465139

A 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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rockefeller University

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

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

  • Drug or alcohol abuse within 12 months
  • Positive drug screen
  • Receipt of certain types of experimental drugs or other treatments, or certain medications
  • Use of systemic immunosuppressive agents (excluding topical steroids) within 12 months
  • History of certain diseases including syphilis, herpes zoster, primary or secondary immunodeficiency
  • Diagnosis with or family history of significant autoimmunity (ex: type I diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma)
  • 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
  • History of asthma requiring any use of inhaled or oral medication within 5 years
  • Herpes zoster within 3 months
  • Donation of blood within 8 weeks, and donation of plasma within 2 weeks

Treatment and study plan

CDX-301

Drug

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

Primary outcomes

  1. Number of reported adverse events

    Time frame: Until day 28 of follow up.

    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 outcomes

  1. Determination of PK profile of CDX301

    Time frame: Until day 28 of follow up or until resolution.

    Levels of CDX301 in circulating blood will be evaluated by measures such as AUC, Cmax, T1/2, and Tmax

  2. 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

Sponsors and collaborators

Lead sponsor

Celldex Therapeutics

Industry

Registry information

Official study title

A Phase 1 Safety, Pharmacokinetic, and Immunologic Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 4, 2011
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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