AB103 Peptide Antagonist in Healthy Volunteers

NCT01166984 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: ATB-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer Safety Study

Keywords

sepsis; septic shock

Outcome Measures

Primary Outcomes (3)

• Number Adverse Events (AEs)

  An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.

  2 weeks

• Number of Serious Adverse Events (SAEs)

  A serious adverse event (SAE) is an AE occurring during any study phase and at any dose of the study drug (AB103 or placebo) that fulfills one or more of the following criteria: * Results in death * Is life-threatening (i.e., the subject was, in the opinion of the Investigator, at immediate risk of death from the event as it occurred) * Requires or prolongs hospitalization * Results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions) * Is a congenital anomaly or birth defect, or * Is an important and significant medical event.

  2 weeks

• Number of Dose-limiting Toxicities (DLTs)

  DLTs were defined as the emergence of one or more selected AEs that reached a threshold that may justify stopping the trial.

  2 weeks

Secondary Outcomes (4)

• Area Under the Plasma Concentration-time Curve (AUC)

  Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

• Cmax

  Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

• Apparent Terminal Plasma Half-life (T1/2)

  Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

• Clearance (CL)

  Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

Study Arms (5)

AB103 7.5 µg/kg

EXPERIMENTAL

AB103 7.5 µg/kg administered as a single IV infusion

Drug: AB103

AB103 37.5 µg/kg

EXPERIMENTAL

AB103 37.5 µg/kg administered as a single IV infusion

Drug: AB103

AB103 150 µg/kg

EXPERIMENTAL

AB103 150 µg/kg administered as a single IV infusion

Drug: AB103

AB103 450 µg/kg

EXPERIMENTAL

AB103 450 µg/kg administered as a single IV infusion

Drug: AB103

Placebo

PLACEBO COMPARATOR

Normal saline (0.9% sodium chloride) administered as a single IV infusion

Drug: Placebo

Interventions

AB103 DRUG

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

AB103 150 µg/kg; AB103 37.5 µg/kg; AB103 450 µg/kg; AB103 7.5 µg/kg

Placebo DRUG

Single intravenous infusion of normal saline (0.9% sodium chloride) administered over approximately 10 minutes

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Atox Bio Ltd: lead

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

AB103

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Results Point of Contact

• Title: Wayne M Dankner, MD, Chief Medical Officer
• Organization: AtoxBio, Ltd.

wayned@atoxbio.com

1 919-219-6377

Study Officials

• Alan Cross, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 21, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 9, 2021
• Results First Posted: April 27, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)