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Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects

NCT02737371 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-05-23

No results posted yet for this study

Summary

Double blind, placebo controlled, ascending multiple (10) oral dose, sequential group study. Twenty-four subjects will complete the study in 3 cohorts (Groups A to C), each group consisting of 8 subjects. Each cohort will consist of 4 male and 4 female subjects. Each subject will be dosed for 10 days and will be on study for approximately 7 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 15 (120 hours post the last dose). The dose will range between 2 and 10 mg/kg daily, given as either a single daily dose or as two doses divided over the 24-hour dosing period.

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

Cohorts will be dosed at least at 3 weekly intervals. There will be a review of the safety and pharmacokinetic data of each cohort prior to each dose escalation.

Conditions

  • Invasive Aspergillosis

Interventions

DRUG

F901318 Dose level A oral

Adverse events days 1-10

DRUG

Placebo dose level A oral

Placebo adverse events days 1-10

DRUG

F901318 Dose level B oral

F901318 adverse events days 1-10

DRUG

Placebo dose level B oral

Placebo adverse events days 1-10

DRUG

F901318 Dose level C oral

F901318 adverse events days 1-10

DRUG

Placebo Dose level C oral

Placebo adverse events days 1-10

Sponsors & Collaborators

  • SimbecRresearch Ltd.

    collaborator UNKNOWN

  • F2G Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Girish Sharma · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-05-22
Completion
2017-05-22

Countries

  • United Kingdom

Study Locations

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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 NCT02737371 on ClinicalTrials.gov