None listed
Conditions
Brief summary
This is a first in human phase 1, randomized, blinded, placebo-controlled single-centre, dose escalation safety and tolerability study that will evaluate 5 doses of FDY-5301 by sequentially increasing the dose of intravenous FDY-5301
Interventions
Ascending dose randomized, blinded, placebo-controlled study involving 5 dosing cohorts of FDY-5301 with 8 participants per cohort. Within each dosing cohort, 6 participant will received FDY-5301 and 2 participants will receive placebo.
Doses being investigated are 0.1 mg/kg. 0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, and 10.0 mg/kg.
Both FDY5301 and placebo will be administered as single intravenous infusion.
As this is an in-patient study, only qualified site staff will be administering FDY5301 o
Ascending dose randomized, blinded, placebo-controlled study involving 5 dosing cohorts of FDY-5301 with 8 participants per cohort. Within each dosing cohort, 6 participant will received FDY-5301 and 2 participants will receive placebo. Doses being investigated are 0.1 mg/kg. 0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, and 10.0 mg/kg. Both FDY5301 and placebo will be administered as single intravenous infusion. As this is an in-patient study, only qualified site staff will be administering FDY5301 or placebo and will monitor compliance by noting when the infusion starts and stops.
Sponsors
Clinical Network Services Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1) Aged between 18 and 65 years (inclusive). 2) Subjects must be infertile or agree to the use of medically reliable contraceptive methods (i.e. double barrier) for the duration of the study and for 30 days after study completion. 3) Body Mass Index (BMI) 18-30 inclusive. 4) Euthyroid confirmed by thyroid function testing at screening. 5) Adequate venous access for venipuncture and cannulation for drug administration. 6) Fluent in the English language. 7) A creatinine clearance of greater than 75 mL/min 8) In good general health as determined by medical screening. 9) Ability to provide informed consent
Exclusion criteria
1) Any chronic illness requiring prescription medication. 2) Presence or history of any thyroid disorder or presence of goiter upon examination 3) History of and/or hypersensitivity reaction to iodide or iodide containing drugs 4) Participation in any investigational study within 30 days of Visit 1. 5) Have donated blood (usually 550 mL) within 30 days of study participation 6) The need to take any over-the-counter (OTC) medications or herbal/vitamin supplements for one week prior to the check-in visit, and during the study 7) The need to take any prescription medications for two weeks prior to the check-in visit, and during the study excluding oral contraceptives, or contraceptive implants. 8) Subjects who are unable to abstain from smoking during study confinement. 9) Females not using medically reliable contraceptive methods (i.e. double barrier) or those who are nursing or pregnant 10) Use of food and/or beverages that contain caffeine or other xanthines (e.g. coffee, tea, cola and chocolate) during the 24 hours prior to dose administration and whilst confined at the clinical facility. 11) Regular drinkers of more than four (4) units of alcohol daily or those who have consumed alcohol within 24 hours pre-dose and until study completion. 12) Acute illness requiring treatment within 30 days of study entry. 13) Any history of clinically significant chronic illness including heart failure, renal failure, or liver disease 14) Have a predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs. 15) Have a history of abnormal bleeding tendencies. 16) History of Hepatitis B, Hepatitis C, acute or chronic hepatitis, or history/demonstration of Human Immunodeficiency Virus (HIV) antibodies or AIDS 17) Current history of alcohol or drug abuse (licit or illicit); or positive urine drug and alcohol screen at screening and pre-dose 18) Have blood pressure readings (after resting for 5 minutes) outside a systolic blood pressure range of 90-140 mmHg or a diastolic blood pressure outside a range of 40-90 on two consecutive measurements 19) Have any evidence of organ dysfunction, or any deviation in clinical laboratory values which is confirmed on re-examination to be clinically significant (i.e. in the opinion of the investigator would jeopardize the safety of the subject or impact the validity of the study results). 20) Inability to provide informed consent.
Outcome results
None listed