None listed
Conditions
Brief summary
This study will assess the safety and PK of the oral drug FT011 in healthy volunteers and in a small number of patients with diabetic nephropathy due to type 2 diabetes mellitus. Results from this study will help determine the development of FT011 as a treatment for diabetic nephropathy.
Interventions
FT011 oral capsules.
Part A: 5 sequential cohorts of healthy volunteers each receiving a single dose of 10, 30, 100, 300 or 1000mg and followed up to Day 7.
Part B: single cohort of healthy volunteers receiving a single dose of 100mg in the fed or fasted state followed by 10 day washout then crossover to a single dose of 100mg in the alternate state. E.g a subject may be randomised to receive the dose while fasted, then will return to receive a dose after a meal, or vice versa. Subjects wi
FT011 oral capsules. Part A: 5 sequential cohorts of healthy volunteers each receiving a single dose of 10, 30, 100, 300 or 1000mg and followed up to Day 7. Part B: single cohort of healthy volunteers receiving a single dose of 100mg in the fed or fasted state followed by 10 day washout then crossover to a single dose of 100mg in the alternate state. E.g a subject may be randomised to receive the dose while fasted, then will return to receive a dose after a meal, or vice versa. Subjects will be followed up to Day 7 after the second dose. Part B may run concurrently with Part A, once Part A 100mg cohort is complete. Part C: 3 cohorts of healthy volunteers followed by 2 cohorts of patients each receiving one dose per day for 14 days, and followed up to Day 21. Dose levels to be determined after Part A is complete. Part C will run after Part A and Part B are complete and safety and dose levels have been reviewed. All subjects (Parts A, B and C) will be resident in clinic for dosing. This will ensure dosing compliance. In each cohort 75% of subjects will receive FT011 and 25% will recieve placebo
Sponsors
Fibrotech Therapeutics Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers (Part A, Part B, Part C): - Male aged 18 to 45 years old inclusive - Good general health without clinically significant medical history - Body mass index < 30 Patients (Part C): - males aged 18 to 70 years old inclusive - have Diabetes Mellitus Type 2 - have overt albuminuria - have eGFR >/= 30 and < / = 60 mL/min - currently taking either an ACEi or an ARB at a stable dose.
Exclusion criteria
Healthy volunteers (Part A, Part B, Part C): - Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose, or an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the Investigational Product. - Have a history of thyroidectomy or thyroid disease that required medication within the past 12 months. - Have had serious angioedema episodes within the previous 3 years or requiring angioedema medication in the previous two years. - Have a bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws. - Have any clinically significant abnormality at Screening (determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead ECG, or positive urine screen for drugs of abuse), a psychiatric condition that precludes compliance with the protocol, or any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk. - Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder; or a history of or current tuberculosis, epilepsy, diabetes or glaucoma Patients (Part C): - Have a history of untreated or uncontrolled proliferative or pre-proliferative diabetic retinopathy - Have evidence of hepatic dysfunction, HbA1c > 11.0%, serum potassium > 6 mmol/L. - Have untreated urinary tract infection or other medical conditions that impact urinary protein values - Have unstable angina pectoris or New York Heart Association Class III or IV congestive heart failure. - Have a history of any major medical condition or any condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk. - Have any risk of bleeding - Use of anticoagulant drugs including warfarin or heparin, low molecular weight heparin, danaparoid, hirudin, or others. - Have other specific renal conditions known to be the cause of renal disease, and patients with other specific, clinically significant renal disease. - Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder; or a history of or current tuberculosis, epilepsy, diabetes or glaucoma.
Outcome results
None listed