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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

July 20, 2010
June 6, 2011
September 2010
June 2011   (final data collection date for primary outcome measure)
maximum tolerated dose [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01166984 on ClinicalTrials.gov Archive Site
  • 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
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.
Not Provided
Not Provided
 
AB103 Peptide Antagonist in Healthy Volunteers
Phase 1, Double Blind, Placebo-Controlled, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Clinical Trial of AB103, A Peptide Antagonist in Healthy Volunteers

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Healthy Volunteer Safety Study
Drug: AB103
AB103 intravenous one infusion
  • Experimental: AB103 Peptide Antagonist
    AB103 Peptide Antagonist given intravenously
    Intervention: Drug: AB103
  • Placebo Comparator: Placebo
    Saline
    Intervention: Drug: AB103
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01166984
ATB-001
Yes
Alan Cross, M.D., University of Maryland School of Medicine
Atox Bio Ltd
Not Provided
Principal Investigator: Alan Cross, MD University of Maryland
Atox Bio Ltd
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP