ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 38 for:    "Hereditary angioedema" | United States

A Single Increasing Dose Study to Assess Safety and Tolerability of DX-2930 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01923207
Recruitment Status : Completed
First Posted : August 15, 2013
Last Update Posted : May 2, 2016
Sponsor:
Collaborator:
Dyax Corp.
Information provided by (Responsible Party):
Shire

Brief Summary:
The purpose of this study is to assess the safety and tolerability of the study drug (DX-2930) administered subcutaneously in healthy subjects. Subjects will be randomized to receive DX-2930 or placebo.

Condition or disease Intervention/treatment Phase
Hereditary Angioedema (HAE) Drug: DX-2930 Drug: Placebo Phase 1

Detailed Description:
Approximately 32 healthy subjects will be randomized to receive DX-2930 or placebo.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Double-Blind, Single Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 (Recombinant Fully Human Antibody Inhibitor of Plasma Kallikrein) in Healthy Subjects
Study Start Date : August 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DX-2930
DX-2930 administered by subcutaneous route
Drug: DX-2930
Placebo Comparator: placebo
inactive formulation of DX-2930
Drug: Placebo
placebo, subcutaneous administration




Primary Outcome Measures :
  1. Proportion of subjects with adverse events [ Time Frame: 112 days ]

Secondary Outcome Measures :
  1. DX-2930 plasma level [ Time Frame: 112 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female subjects who are 18 to 55 years of age, inclusive.
  2. Willing and able to read, understand, and sign an informed consent form.
  3. Willing and able to receive subcutaneous injections.
  4. Body mass index (BMI) of 18 to 33 kg/m2 with a weight of at least 60 kg for males and at least 50 kg for females, with a maximum weight of 130 kg for any subject.
  5. Medically healthy as determined by the investigator via assessment of physical examination, medical history, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
  6. Females of childbearing potential must agree to be abstinent or else use any two of the following medically acceptable forms of contraception from the Screening Period through 30 days after the final study visit: condom with spermicidal jelly, diaphragm or cervical cap with spermicidal jelly, or intra-uterine device (IUD). A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception. Female subjects must agree to practice the above birth control methods for 30 days after the final study visit as a safety precaution.
  7. Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months (and confirmed with a screening follicle-stimulating hormone (FSH) level in the post-menopausal range), do not require contraception during the study.
  8. Males with female partners of childbearing potential must agree to use a highly effective, medically acceptable form of contraception from the screening period through 60 days after the final study visit. All male subjects, including males who are surgically sterile (post vasectomy), must agree to practice the above birth control methods for 60 days from the final study visit as a safety precaution.

Exclusion Criteria:

  1. Any active acute or chronic illness at screening.
  2. Any history of exposure to a biologic within 90 days prior to dosing.
  3. Receipt of any investigational (a non-licensed, non-approved) drug or device within 60 days prior to dosing.
  4. Any prior history of exposure to a monoclonal antibody.
  5. Pregnant or actively breastfeeding.
  6. Any history of substance abuse or dependence.
  7. Positive urine drug or alcohol test at screening or Day -1 for amphetamines, benzodiazepines, barbiturates, cocaine, cotinine (detection mechanism for nicotine), marijuana, opiates, phencyclidine or ethanol.
  8. Regular use of alcohol within six months prior to the screening visit [more than fourteen units of alcohol per week (1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol)].
  9. Use of prescription or over-the-counter medication within 14 days prior to administration of study medication, or use of over-the-counter products (dietary or herbal supplements and vitamins) within 14 days prior to administration of study medication.
  10. Use of nicotine or nicotine-containing products within the previous three months prior to screening.
  11. Subject has any other condition, which in the opinion of the investigator may compromise the safety or compliance or would preclude the subject from successful completion of the study or interfere with the interpretation of the results.
  12. Abnormal clinical laboratory values and/or other study assessments such as ECG results deemed to be clinically significant by the investigator.
  13. Donation of blood within 60 days preceding Study Day -1.
  14. Serology testing positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923207


Locations
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Shire
Dyax Corp.

Publications of Results:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01923207     History of Changes
Other Study ID Numbers: DX-2930-01
First Posted: August 15, 2013    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Angioedemas, Hereditary
Angioedema
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn