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AB103 Peptide Antagonist in Healthy Volunteers

NCT01166984 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-06-09

Study results available
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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

Interventions

DRUG

AB103

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Atox Bio Ltd

    lead INDUSTRY

Principal Investigators

  • Alan Cross, MD · University of Maryland, College Park

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-06-30
Completion
2011-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166984 on ClinicalTrials.gov