F901318 Single Ascending Dose Study in Healthy Male Volunteers

NCT02142153 | Completed Phase 1 Results

• 2 other identifiers: F901318-01-01-142014-000823-25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

First in man; Antifungal; Intravenous infusion; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Adverse Events

  Adverse events will be collected from the time of screening until the final study visit

  Single dose

Secondary Outcomes (1)

• Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities

  Single dose

Other Outcomes (1)

• Pharmacokinetics

  Single dose

Study Arms (10)

F901318 0.25 mg/kg

EXPERIMENTAL

Single intravenous infusion over 4 hours

Drug: F901318

0.25 mg/kg placebo

PLACEBO COMPARATOR

Single intravenous infusion over 4 hours

Drug: Placebo

F901318 0.75 mg/kg

EXPERIMENTAL

Single intravenous infusion over 4 hours

Drug: F901318

Placebo 0.75 mg/kg

PLACEBO COMPARATOR

Single intravenous infusion over 4 hours

Drug: Placebo

F901318 1.5 mg/kg

EXPERIMENTAL

Single intravenous infusion over 4 hours

Drug: F901318

Placebo 1.5 mg/kg

PLACEBO COMPARATOR

Single intravenous infusion over 4 hours

Drug: Placebo

F901318 mg/kg

EXPERIMENTAL

Single intravenous infusion over 4 hours

Drug: F901318

Placebo 3 mg/kg

PLACEBO COMPARATOR

Single intravenous infusion over 4 hours

Drug: Placebo

F901318 5 mg/kg

EXPERIMENTAL

Single intravenous infusion over 4 hours

Drug: F901318

Placebo 5 mg/kg

PLACEBO COMPARATOR

Single intravenous infusion over 4 hours

Drug: Placebo

Interventions

F901318 DRUG

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

F901318 0.25 mg/kg; F901318 0.75 mg/kg; F901318 1.5 mg/kg; F901318 5 mg/kg; F901318 mg/kg

Placebo DRUG

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

0.25 mg/kg placebo; Placebo 0.75 mg/kg; Placebo 1.5 mg/kg; Placebo 3 mg/kg; Placebo 5 mg/kg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-90 kg inclusive
• Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is acceptable)
• Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

You may not qualify if:

• Male subjects who are not, or whose partners are not willing to use appropriate contraception (such as a condom) with established use of oral, injected or implanted hormonal contraceptive, intrauterine device or diaphragm with spermicide for three months after the last dose
• Subjects who have received any prescribed systemic or topical medication within 14 days of dosing with study drug unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
• Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of dosing with study drug (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
• Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of dosing with study drug unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
• Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical or biological entity) in the past 3 months

Sponsors & Collaborators

• F2G Biotech GmbH: lead
• Simbec Research: collaborator

Study Sites (1)

Simbec Research

Merthyr Tydfil, Mid Glamorgan, CF48 4DR, United Kingdom

Location

MeSH Terms

Interventions

olorofim

Results Point of Contact

• Title: Dr Anthony Kennedy
• Organization: F2G

TKennedy@f2g.com

0044 161 785 1273

Study Officials

• Salvatore Febbraro, MD

  Simbec Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 20, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 7, 2015
• Results First Posted: September 7, 2015

Record last verified: 2015-06

Locations

GB (1)