- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01923207
A Single Increasing Dose Study to Assess Safety and Tolerability of DX-2930 in Healthy Subjects
May 13, 2021 updated by: Shire
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Approximately 32 healthy subjects will be randomized to receive DX-2930 or placebo.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States, 66212
- Vince and Associates Clinical Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects who are 18 to 55 years of age, inclusive.
- Willing and able to read, understand, and sign an informed consent form.
- Willing and able to receive subcutaneous injections.
- 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.
- Medically healthy as determined by the investigator via assessment of physical examination, medical history, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
- 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.
- 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.
- 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:
- Any active acute or chronic illness at screening.
- Any history of exposure to a biologic within 90 days prior to dosing.
- Receipt of any investigational (a non-licensed, non-approved) drug or device within 60 days prior to dosing.
- Any prior history of exposure to a monoclonal antibody.
- Pregnant or actively breastfeeding.
- Any history of substance abuse or dependence.
- 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.
- 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)].
- 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.
- Use of nicotine or nicotine-containing products within the previous three months prior to screening.
- 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.
- Abnormal clinical laboratory values and/or other study assessments such as ECG results deemed to be clinically significant by the investigator.
- Donation of blood within 60 days preceding Study Day -1.
- Serology testing positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DX-2930
DX-2930 administered by subcutaneous route
|
|
Placebo Comparator: placebo
inactive formulation of DX-2930
|
placebo, subcutaneous administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects with adverse events
Time Frame: 112 days
|
112 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
DX-2930 plasma level
Time Frame: 112 days
|
112 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 12, 2013
Primary Completion (Actual)
January 7, 2014
Study Completion (Actual)
January 7, 2014
Study Registration Dates
First Submitted
August 8, 2013
First Submitted That Met QC Criteria
August 13, 2013
First Posted (Estimate)
August 15, 2013
Study Record Updates
Last Update Posted (Actual)
May 17, 2021
Last Update Submitted That Met QC Criteria
May 13, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Vascular
- Hypersensitivity
- Urticaria
- Hereditary Complement Deficiency Diseases
- Primary Immunodeficiency Diseases
- Angioedema
- Angioedemas, Hereditary
Other Study ID Numbers
- DX-2930-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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