AB103 Peptide Antagonist in Healthy Volunteers
Condition: Healthy Volunteer Safety Study
Intervention: AB103; Placebo
Intervention description: Single intravenous infusion at doses of 7.5 µg/kg, 37.5 µg/kg, 150 µg/kg, or 450 µg/kg administered over approximately 10 minutes; Single intravenous infusion of normal saline (0.9% sodium chloride) administered over approximately 10 minutes
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: sepsis; septic shock

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.
    

Eligibility 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.