AB103 Peptide Antagonist in Healthy Volunteers

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. Identifier: NCT01166984
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : June 8, 2011
Information provided by:
Atox Bio Ltd

Brief Summary:
The primary objective of this study is to establish the safety profile and maximum tolerated dose of AB103 given as a single intravenous infusion or by repeated (5 days) IV infusions in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Safety Study Drug: AB103 Phase 1

Detailed Description:
AB103 is being developed as a therapeutic to treat severe sepsis and septic shock resulting from bacterial infections. This will be a Phase 1, single center, randomized, double-blind, placebo-controlled, sequential-dose escalation study in approximately 34 healthy volunteers with an LPS challenge cohort following the dose escalation phase.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Phase 1, Double Blind, Placebo-Controlled, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Clinical Trial of AB103, A Peptide Antagonist in Healthy Volunteers
Study Start Date : September 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: AB103 Peptide Antagonist
AB103 Peptide Antagonist given intravenously
Drug: AB103
AB103 intravenous one infusion
Placebo Comparator: Placebo
Drug: AB103
AB103 intravenous one infusion

Primary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) [ Time Frame: 1 Day ]
    PK parameters of AB103 including Cmax, Tmax, area under the plasma concentration-time curve (AUC), apparent t½, and CL, will be determined.

  2. Tolerability [ Time Frame: From Infusion to final followup ]
    Tolerability will be determined by the reporting of adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01166984

United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Atox Bio Ltd
Principal Investigator: Alan Cross, MD University of Maryland

Responsible Party: Alan Cross, M.D., University of Maryland School of Medicine Identifier: NCT01166984     History of Changes
Other Study ID Numbers: ATB-001
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by Atox Bio Ltd:
septic shock