AB103 Peptide Antagonist in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Atox Bio Ltd
ClinicalTrials.gov Identifier:
NCT01166984
First received: July 20, 2010
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Healthy Volunteer Safety Study
Drug: AB103
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Atox Bio Ltd:

Primary Outcome Measures:
  • maximum tolerated dose [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK) [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    PK parameters of AB103 including Cmax, Tmax, area under the plasma concentration-time curve (AUC), apparent t½, and CL, will be determined.

  • Tolerability [ Time Frame: From Infusion to final followup ] [ Designated as safety issue: Yes ]
    Tolerability will be determined by the reporting of adverse events


Enrollment: 25
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AB103 Peptide Antagonist
AB103 Peptide Antagonist given intravenously
Drug: AB103
AB103 intravenous one infusion
Placebo Comparator: Placebo
Saline
Drug: AB103
AB103 intravenous one infusion

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166984

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

No publications provided

Responsible Party: Alan Cross, M.D., University of Maryland School of Medicine
ClinicalTrials.gov Identifier: NCT01166984     History of Changes
Other Study ID Numbers: ATB-001
Study First Received: July 20, 2010
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Atox Bio Ltd:
sepsis
septic shock

ClinicalTrials.gov processed this record on April 17, 2014