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NCT00952263 · ClinicalTrials.gov registry record · Phase 1
Study in Healthy Volunteers to Evaluate a Human Monoclonal Antibody Against Hepatitis C
A Phase 1 study of Healthy, sponsored by MassBiologics.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT00952263 is a Phase 1 study of Healthy that has completed, run by MassBiologics. The registered enrollment target is 31 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00952263, a Phase 1 study of Healthy, has completed, sponsored by MassBiologics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I, open-label, dose escalation study to evaluate the safety of MBL-HCV1 in healthy adult volunteers. Eligible volunteers will be admitted to a phase 1 unit for study infusion. A single dose of human monoclonal antibody will be administered. The study duration is 56 days. During this time, safety will be assessed via physical examinations, laboratory testing, concomitant medication usage and review of treatment emergent adverse events should they occur. Pharmacokinetics will be derived from analysis of blood samples obtained during the 56 day study.
Conditions Studied
Interventions
- BIOLOGICAL MBL-HCV1
Study Locations (1)
Minnesota
- DaVita Clinical Research - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2009-07 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00952263
The ClinicalTrials.gov registry entry for NCT00952263 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The listed sponsor is MassBiologics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which MBL-HCV1 is the first listed.
NCT00952263 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT00952263 about?
NCT00952263 is a clinical study titled "Study in Healthy Volunteers to Evaluate a Human Monoclonal Antibody Against Hepatitis C". This is a phase I, open-label, dose escalation study to evaluate the safety of MBL-HCV1 in healthy adult volunteers. Eligible volunteers will be admitted to a phase 1 unit for study infusion. A single dose of human monoclonal antibody will be administered. The study duration is 56 days. During this ...
What is the current status of trial NCT00952263?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2009-07. Estimated completion is 2009-12.
What conditions does trial NCT00952263 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00952263?
The interventions under investigation include: MBL-HCV1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00952263?
This trial is sponsored by MassBiologics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00952263 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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