Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Subjects



Status:Completed
Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2014
End Date:May 2015

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A Phase 1b, Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Subjects

The purpose of this study is to evaluate the safety, tolerability, and PK profile of
multiple subcutaneous administrations of DX-2930 across a range of doses in HAE subjects.


Inclusion Criteria:

- At least 18 years of age at the time of screening.

- Documented diagnosis of HAE (Type I or II)

- Experiencing ≥2 HAE attacks per year, with at least 1 attack in the past 6 months
reported by the subject.

- Willing and able to read, understand, and sign an informed consent form.

- Females of childbearing potential must agree to be abstinent or else use acceptable
forms of contraception throughout study

- Males with female partners of childbearing potential must agree to be abstinent or
use a medically acceptable form of contraception throughout study.

Exclusion Criteria:

- Exposure to an investigational drug or device within 90 days prior to study.

- History of exposure within the past 5 years to a monoclonal antibody or recombinant
protein bearing an Fc domain.

- Concomitant diagnosis of another form of chronic angioedema

- Use of long-term prophylaxis for HAE within 90 days prior to study.

- Use of C1-INH that exceeds a total of 30 days within the past 90 days prior to study;
any use of C1-INH within 7 days prior to study.

- Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing
medications with systemic absorption within 90 days prior to study.

- Exposure to androgens within 90 days prior to study.

- Presence of an indwelling catheter.

- Diagnosis of HIV.

- Active liver disease or liver function test abnormalities

- History of substance abuse or dependence.

- Pregnancy or breastfeeding.

- Any condition that, in the opinion of the Investigator, may compromise their safety
or compliance, preclude successful conduct of the study, or interfere with
interpretation of the results
We found this trial at
13
sites
Dallas, Texas 75231
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Boston, MA
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Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Cincinnati, Ohio 45267
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Cincinnati, OH
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Hershey, Pennsylvania 17033
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Hershey, PA
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Lake Oswego, OR
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Milano, MI 20157
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Milano,
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Mineola, NY
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New York, NY
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San Diego, California 92122
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San Diego, CA
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St. Louis, Missouri 63108
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St. Louis, MO
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Tampa, FL
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Walnut Creek, California 94598
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Walnut Creek, CA
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