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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01166984 |
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Date of registration:
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20/07/2010 |
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Primary sponsor: |
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Public title:
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AB103 Peptide Antagonist in Healthy Volunteers
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Scientific title:
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Phase 1, Double Blind, Placebo-Controlled, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Clinical Trial of AB103, A Peptide Antagonist in Healthy Volunteers |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01166984 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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Countries of recruitment
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United States
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Contacts
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Name:
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Alan Cross, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Maryland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Be 18-to-40 years-of-age.
- Have adequate venous access.
- Have a body mass index between 20 and 29 kg/m2.
- Have a history and physical examination that demonstrate no clinically significant
contraindication for participating in the study, in the judgment of the admitting
physician and/or the site investigator.
- Have vital signs as follows: resting heart rate between 50 and 90 bpm, systolic BP
below 150 mm Hg and diastolic BP below 90 mm Hg.
- Have all blood chemistry, hematology, coagulation, and urinalysis analyte levels
within 10% of normal laboratory limits.
- If female, not be pregnant or breast-feeding, nor plan to become pregnant for the
duration of the study, have a negative pregnancy test.
- Agree to exercise adequate birth control from the time of the screening procedures to
14 days after the investigational agent administration (both males and females).
- Have an ECG performed that demonstrates normal sinus rhythm, normal conductivity, and
no clinically significant arrhythmias.
Exclusion Criteria:
- Be pregnant or lactating.
- Have autoimmune disease or asthma.
- Have been febrile within 3-days of the first infusion.
- Have a history of migraine headaches, as diagnosed by a physician.
- Have any acute or chronic medical illnesses or other condition that, in the opinion
of the Investigator, might jeopardize the safety of the patient, or the adequate
evaluation of study results.
- Be taking any medications to treat a chronic medical condition.
- Have participated in a research study where they received any experimental products
within 30 days prior to study entry.
- Have ongoing drug abuse/dependence (including alcohol) by medical history.
- Have taken, within 14 days of planned dosing, any prescription or non-prescription
medication (including ibuprofen, aspirin, of non-steroidal anti-inflammatory drugs)
unless the Principal Investigator/Sub-Investigator, in consultation with the Medical
Monitor, provides a statement justifying that the medication taken will not impact
the results of this study (with rare exceptions taking prescription drugs will be
grounds for exclusion).
- Have donated a unit of blood within the preceding 4-week period.
- Have allergy to either sulfa- or penicillin-based drugs.
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteer Safety Study
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Intervention(s)
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Drug: AB103
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Primary Outcome(s)
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maximum tolerated dose
[Time Frame: 1 week]
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Secondary Outcome(s)
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Pharmacokinetics (PK)
[Time Frame: 1 Day]
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Tolerability
[Time Frame: From Infusion to final followup]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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