AB103 Peptide Antagonist in Healthy Volunteers

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to establish the safety profile and maximum tolerated dose (MTD) of AB103 given as a single intravenous (IV) infusion in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atox Bio Ltd

Criteria

Inclusion Criteria:

• Be able to read, understand and sign the Informed Consent form and be willing to participate in all study procedures for the duration of the study.

• 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 beats per minute (bpm), systolic blood pressure (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 electrocardiogram (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.

• Have a history of vagal responses resulting in bradycardia.