Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody

NCT ID: NCT01594437

Last Updated: 2014-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Human cytomegalovirus (HCMV) disease remains an unmet medical need: In the US, the estimated prevalence of congenital HCMV infection is \~1% and is one of the leading causes of permanent hearing loss and neurological deficits in children. In immunocompromised individuals such as transplant recipients it can cause serious life-threatening disease and may significantly increase the risk of graft rejection. As existing therapies for HCMV can have serious side effects, there remains a medical need for safe and effective treatment of HCMV disease.

Conditions

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Cytomegalovirus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TCN-202

Group Type EXPERIMENTAL

TCN-202

Intervention Type BIOLOGICAL

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

One or two doses administered by intravenous infusion.

Interventions

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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.

Intervention Type BIOLOGICAL

Placebo

One or two doses administered by intravenous infusion.

Intervention Type BIOLOGICAL

Other Intervention Names

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Human Anti-Cytomegalovirus Monoclonal Antibody 0.9% Sodium chloride for Injection, USP

Eligibility Criteria

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Inclusion Criteria

* Healthy adult volunteers
* Normal lab tests

Exclusion Criteria

* Prior treatment with monoclonal antibody
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Theraclone Sciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed Al-Ibrahim, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

SNBL Clinical Pharmacology Center

Locations

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SNBL Clinical Pharmacology Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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TCN-202-001

Identifier Type: -

Identifier Source: org_study_id

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