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Trial record 3 of 15 for:    DX-2930

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 : November 14, 2018
Sponsor:
Collaborator:
Dyax Corp.
Information provided by (Responsible Party):
Shire

Tracking Information
First Submitted Date  ICMJE August 8, 2013
First Posted Date  ICMJE August 15, 2013
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE August 12, 2013
Actual Primary Completion Date January 7, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2013)
Proportion of subjects with adverse events [ Time Frame: 112 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2013)
DX-2930 plasma level [ Time Frame: 112 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single Increasing Dose Study to Assess Safety and Tolerability of DX-2930 in Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Approximately 32 healthy subjects will be randomized to receive DX-2930 or placebo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hereditary Angioedema (HAE)
Intervention  ICMJE
  • Drug: DX-2930
  • Drug: Placebo
    placebo, subcutaneous administration
Study Arms  ICMJE
  • Experimental: DX-2930
    DX-2930 administered by subcutaneous route
    Intervention: Drug: DX-2930
  • Placebo Comparator: placebo
    inactive formulation of DX-2930
    Intervention: Drug: Placebo
Publications * Chyung Y, Vince B, Iarrobino R, Sexton D, Kenniston J, Faucette R, TenHoor C, Stolz LE, Stevens C, Biedenkapp J, Adelman B. A phase 1 study investigating DX-2930 in healthy subjects. Ann Allergy Asthma Immunol. 2014 Oct;113(4):460-6.e2. doi: 10.1016/j.anai.2014.05.028. Epub 2014 Jun 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2013)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 7, 2014
Actual Primary Completion Date January 7, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01923207
Other Study ID Numbers  ICMJE DX-2930-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Dyax Corp.
Investigators  ICMJE Not Provided
PRS Account Shire
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP