MedTrace Logo

Single Ascending Oral Dose Study of F901318

NCT02394483 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2016-09-19

No results posted yet for this study

Summary

Double blind, placebo controlled, ascending single oral dose, sequential group study. Forty subjects will complete the study in 5 cohorts (Groups A to E), each group consisting of 8 subjects. Each subject will be on study for approximately 6 weeks. Each subject will participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 6 (120 hours post-dose). Each cohort will be dosed in a leading edge design in which two subjects will receive study drug (1 active and 1 placebo) on the first dosing day, and the last 6 will receive study drug (5 active and 1 placebo) on the second dosing day.

All subjects will return for a post-study visit 8 to 10 days after the dose of study medication.

Cohorts will be dosed at 2 weekly intervals. There will be a review of safety data, after the first two subjects have been dosed and before dosing of the subsequent six subjects. There will be a complete review of safety and pharmacokinetic data of each cohort prior to each dose escalation.

Conditions

  • Invasive Aspergillosis

Interventions

DRUG

F901318 safety

Safety assessments

DRUG

F901318 tolerability

Tolerability assessments

DRUG

F901318 pharmacokinetics

Pharmacokinetic assessments

OTHER

Placebo safety

Safety assessments

OTHER

Placebo tolerability

Placebo tolerability

OTHER

Placebo pharmacokinetics

Plaacebo pharmacokinetics

Sponsors & Collaborators

  • Simbec-Orion Group

    collaborator INDUSTRY

  • F2G Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Girish Sharma · Simbec Orion Ltd

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
2015-10-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT02394483 on ClinicalTrials.gov