CompletedNCT01790087Updated May 20, 2015

ANX-188 Thorough QT/QTc Study in Healthy Volunteers

A Phase 1 interventional study of ANX-188 Therapeutic Dose and ANX-188 Supratherapeutic dose in Healthy, sponsored by Mast Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-20.

Sponsored by Mast Therapeutics, Inc. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

This study has been designed in compliance with the ICH-E14 guideline (2005) to evaluate the effect of ANX-188 at therapeutic and supratherapeutic concentrations on cardiac repolarization, specifically, Fridericia's QT-Interval (QTcF)

Conditions studied

Healthy

In context

Lead sponsor

Mast Therapeutics, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy male and female subjects aged 18 to 65 (inclusive) in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory testing at screening.

Exclusion criteria

Exclusion Criteria:

Participation in a clinical trial within the last 60 days
Pregnant or lactating females
Use of prescription drugs, herbals, or over-the-counter medications within 14 days prior to study day -2
Uncontrolled cardiac arrhythmias, cardiac valve abnormalities, or not in normal sinus rhythm
Smokers or tobacco product user in the prior 3 months
Presence of clinically significant illness
Other protocol defined inclusion/exclusion criteria may apply

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 72 participants (actual)

Study arms

Experimental
ANX-188 Therapeutic dose level
IV administration. 100 mg/kg for one hour followed by 30 mg/kg/hour for five hours
Drug: ANX-188 Therapeutic Dose
Experimental
ANX-188 Supratherapeutic dose
IV administration. 300 mg/kg for one hour followed by 200 mg/kg/hr for five hours
Drug: ANX-188 Supratherapeutic dose
Placebo comparator
Saline
IV administration. Six hour infusion.
Drug: Saline
Active comparator
Moxifloxacin
Oral tablet. 400 mg.
Drug: Moxifloxacin

Interventions

DrugANX-188 Therapeutic Dose
Also known as: vepoloxamer
DrugANX-188 Supratherapeutic dose
Also known as: vepoloxamer
DrugSaline
Also known as: Placebo Comparator
DrugMoxifloxacin
Also known as: Active Comparator

What researchers measure

Primary outcomes

Evaluate the effect of therapeutic and supratherapeutic doses of ANX-188 on cardiac ventricular repolarization, specifically, the Fridericia's corrected QT-Interval (QTcF)
Time frame: Day 1 Pre-dose to 24 hours post-dose

Secondary outcomes

Bazett's corrected QT-interval (QTcB)
Time frame: Pre-dose to 24 hours post-dose
Heart rate measurements on treatment compared to time-matched baseline and placebo
Time frame: Pre-dose to 24 hours post-dose
RR-interval on treatment compared to time-matched baseline and placebo
Time frame: Pre-dose to 24 hours post-dose
QRS measurements on treatment compared to time-matched baseline and placebo
Time frame: Pre-dose to 24 hours post-dose
PR interval measurements on treatment compared to time-matched baseline and placebo
Time frame: Pre-dose to 24 hours post-dose
Overall characterization of normal and abnormal ECGs and the number and percentage of subjects with normal and abnormal ECGs
Time frame: Pre-dose to 24 hours post-dose
Number and percentage of subjects that develop abnormalities of repolarization on treatment
Time frame: Pre-dose to 24 hours post-dose
Number and percentage of subjects the develop abnormal U waves
Time frame: Pre-dose to 24 hours post-dose
Relationship between changes from the baseline and placebo in QTcF (DDQTcF)
Time frame: Pre-dose to 24 hours post-dose
Analysis for arrhythmias
Time frame: Pre-dose to 24 hours post-dsoe
Correlation of ECG findings with clinical adverse events
Time frame: Pre-dose to 24 hours post-dose

Study locations

1 site

Research Site
Baltimore, Maryland 20201, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01790087
Lead sponsor: Mast Therapeutics, Inc.
Responsible party: Sponsor
First posted: Feb 13, 2013
Start date: Feb 2013
Primary completion: Apr 2013
Completion: Jun 2013
Last update: May 20, 2015

Study contacts

Edwin L Parsley, D.O.

study director · Mast Therapeutics

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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