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Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

NCT01594437 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-03-21

No results posted yet for this study

Summary

The purpose of this study is to compare the safety profile in healthy adult volunteers of single or multiple intravenous administrations of TCN-202 as compared with placebo.

Conditions

  • Cytomegalovirus Infections

Interventions

BIOLOGICAL

TCN-202

Human monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV. One or two doses will be administered by intravenous infusion.

BIOLOGICAL

Placebo

One or two doses administered by intravenous infusion.

Sponsors & Collaborators

  • Theraclone Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Mohamed Al-Ibrahim, MD, FACP · SNBL Clinical Pharmacology Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-12-31
Completion
2013-03-31

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 NCT01594437 on ClinicalTrials.gov