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ANX-042 Healthy Volunteer Dose Escalation Study

NCT01638104 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-10-13

No results posted yet for this study

Summary

The purpose of this study was to investigate the safety and tolerability of ANX-042 when administered by continuous intravenous (IV) infusion in healthy volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ANX-042

Reconstituted in Sterile Water for Injection, United States Pharmacopeia (USP) and administered by 12 hour continuous intravenous infusion with 5% dextrose in water (D5W), United States Pharmacopeia (USP)

DRUG

Placebo

Administered once by 12 hour continuous intravenous infusion with D5W (USP)

Sponsors & Collaborators

  • Anexon, Incorporated

    collaborator INDUSTRY

  • Celerion

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-12-31
Completion
2012-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01638104 on ClinicalTrials.gov