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A Phase Ib Study of NVX-508 in Sickle Cell Disease

NCT03013426 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-07-16

No results posted yet for this study

Summary

This Phase 1b study in adults with sickle cell disease (SCD) in steady-state (non-acutely ill) aims to evaluate safety and toxicity of NVX-508 in a multi-dosing paradigm as well as to determine the maximum tolerated dose (MTD) in this population. The information gained from this study will be used in making decisions about the appropriate dose(s) and dosing schedule in future multicenter studies of the efficacy of NVX-508 in the treatment of vaso-occlusive episodes (VOE).

Conditions

Interventions

DRUG

NVX-508

Administration of NVX-508 emulsion intravenously

Sponsors & Collaborators

  • NuvOx LLC

    collaborator INDUSTRY

  • Noguchi Memorial Institute for Medical Research

    collaborator OTHER

  • Amma Owusu-Ansah, MD

    lead OTHER

Principal Investigators

  • Amma T Owusu-Ansah, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Drug
Yes

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Entities

Diseases

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 NCT03013426 on ClinicalTrials.gov