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F901318 Single Ascending Dose Study in Healthy Male Volunteers

NCT02142153 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-09-07

Study results available
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Summary

F901318 is a potent new antifungal agent for the treatment of systemic fungal infections. This study will test it for the first time in man with the objective of assessing its safety, tolerability and pharmacokinetic profile.

Conditions

  • Invasive Aspergillosis

Interventions

DRUG

F901318

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile

DRUG

Placebo

Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • F2G Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Salvatore Febbraro, MD · Simbec 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
2014-08-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United Kingdom

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 NCT02142153 on ClinicalTrials.gov