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F901318 Multiple Ascending Dose Study

NCT02342574 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-09-19

No results posted yet for this study

Summary

Double blind, placebo controlled, parallel group ascending dose study evaluating single and multiple (x8 days) dose levels of F901318 in groups of male healthy subjects with the objective of defining a dosing schedule for phase ll clinical trials. F901318, a novel and potent antifungal agent for the treatment of invasive aspergillosis, will be delivered intravenously in a range of dosing schedules driven by pharmacokinetic evaluation in real time. Safety and tolerability of those schedules will also be assessed.

Conditions

  • Invasive Aspergillosis

Interventions

DRUG

F901318

Administration of active compound

DRUG

Placebo

Administration of placebo

Sponsors & Collaborators

  • Hammersmith Medicines Research

    collaborator OTHER

  • F2G Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Frans van den Berg, MB ChB · Hammersmith Medicines Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United Kingdom

Study Locations

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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 NCT02342574 on ClinicalTrials.gov