Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2019-10-29
2020-06-26
Brief Summary
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Detailed Description
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This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 in healthy subjects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CDX-0159
Eligible subjects will receive a single dose of CDX-0159
CDX-0159
Single dose of one of four dosages of CDX-0159
Normal saline
Subjects assigned to receive placebo will receive a single dose of normal saline
Normal saline
Single infusion of normal saline
Interventions
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CDX-0159
Single dose of one of four dosages of CDX-0159
Normal saline
Single infusion of normal saline
Eligibility Criteria
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Inclusion Criteria
* Healthy volunteer aged 18-55.
* In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results.
* Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 30 kg/m2
* No medication other than mild analgesics, vitamins and mineral supplements or, oral contraceptives
* Both males and females of child bearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards.
* Not a current smoker (or regular user of any nicotine containing product).
* Willing to follow all study rules
Exclusion Criteria
* History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication
* Autoimmune disorders requiring more than topical medication
* History of asthma requiring the use of inhaled medication within the past 5 years.
* Vaccination with live vaccines within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
* Positive urine test for alcohol and drugs of abuse.
18 Years
55 Years
ALL
Yes
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, United States
Countries
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Other Identifiers
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CDX0159-01
Identifier Type: -
Identifier Source: org_study_id
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