None listed
Conditions
Brief summary
Placebo-controlled, First-In-Human study assessing the safety and tolerability of PRN1008 in healthy volunteers. Participants will be randomised to receive a single oral dose of PRN1008 or a single oral dose of placebo. Up to four cohorts of eligible participants will be studied.
Interventions
This placebo-controlled, First-In-Human study is looking at the safety and tolerability of a single dose and multiple dose of study drug PRN1008 in healthy volunteers.
The study is designed into two parts:
Single Dose (Part A):
Each participant will be randomised to receive either a single dose (50mg, 150mg, 300mg, 600mg, 1200mg or 1800mg) of PRN1008 oral liquid or a single dose of matching placebo (6 active: 2 placebo, N=8 per cohort). 6 dosing cohorts may be evaluated. Dosing will be escalat
This placebo-controlled, First-In-Human study is looking at the safety and tolerability of a single dose and multiple dose of study drug PRN1008 in healthy volunteers. The study is designed into two parts: Single Dose (Part A): Each participant will be randomised to receive either a single dose (50mg, 150mg, 300mg, 600mg, 1200mg or 1800mg) of PRN1008 oral liquid or a single dose of matching placebo (6 active: 2 placebo, N=8 per cohort). 6 dosing cohorts may be evaluated. Dosing will be escalated upon review of safety and tolerability of each cohort. Multiple Dose (Part B) Each participant will be randomised to receive active or placebo drug either once daily (orally) or twice daily (orally) for ten days. Up to five cohorts of eligible participants will be studied. The planned doses of either PRN1008 oral liquid or matching placebo are 300mg once daily, 300mg twice daily, 600mg once daily or 900mg once daily (8 active: 2 placebo, N=10 per cohort) An optional cohort of either 600mg twice daily or 1200mg once daily may be studied depending on the evaluation of the PK, PD and safety data. 6 dosing cohorts may be evaluated. Dosing will be escalated upon review of safety and tolerability of each cohort For both Part A and Part B, All doses will be administered in the clinic and directly observed by study personnel to ensure compliance. Participants in Part A will be admitted to the clinic on day -1 and remain domiciled until day 3. Participants in Part B will be admitted on Day -1 or -2 and domiciled until Day 12.
Sponsors
Clinical Network Services (CNS) 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 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening 2. Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 30.5 (kg/m2) (inclusive) and a minimum body weight of 45 kg 3. Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study 4. If male, agrees to be sexually abstinent or to use a condom or other adequate barrier method of contraception when engaging in sexual activity from study check-in until 30 days post dosing completion of the follow-up visit. Participants will be advised to use adequate contraception for 30 days following the last administration of the study drug, and not to donate sperm during this same period of time. 5. Female participants must be surgically sterile or post-menopausal (no spontaneous menstrual period for at least one year, confirmed by FSH > 40 mIU/mL. Sterilization procedure must have been completed at least 6 months prior to the first study drug administration. The following are acceptable: a. Essure (Registered Trademark) sterilization (with a copy of the confirmation test) and be using an adequate barrier method (condom or diaphragm) throughout the study b. bilateral tubal ligation and be using an adequate barrier method (condom or diaphragm) throughout the study c. hysterectomy d. bilateral oophorectomy 6. Negative urine drug/alcohol breath testing at screening and check-in (Day -1).
Exclusion criteria
1.Pregnant or lactating women, and male partners of women who are pregnant or lactating 2. Women of child-bearing potential 3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV) 4. Any active acute or chronic disease judged to be clinically significant by the Investigator 5. Use of more than 1-2 tobacco/nicotine-containing products per month within 6 months prior to the first study drug administration 6. Participant is febrile, temperature greater than 37.5 degrees Celsius. 7. History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration 8. History of any significant (as determined by the Investigator) drug-related allergic reactions such as, anaphylaxis, Stevens-Johnson syndrome, urticaria or multiple drug allergies 9. Use of any vitamins or nutritional supplements within the 7 days prior to Day 1. Use of any prescription medication within the 14 days prior to the first study drug administration or five half-lives, whichever is longer 10. Blood donation or significant blood loss within 60 days prior to screening 11. Plasma donation within 14 days prior to the first study drug administration 12. Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 60 days prior to the first study drug administration or five half-lives, whichever is longer 13. Surgery within the past three months prior to the first study drug administration determined by the Investigator to be clinically relevant 14. Personal or family history of prolonged QT syndrome or family history of sudden death 15. QTcF greater than 450 msec (males) or greater than 470 msec (females) or less than 300 msec at screening or baseline visit, or deemed clinically insignificant by the PI 16. Screening ECG with QRS and/or T-wave judged to be unfavorable for a consistently accurate QT measurement as judged by the Investigator 17. Evidence of atrial fibrillation, atrial flutter, complete bundle branch block, Wolff-Parkinson-White Syndrome, or cardiac pacemaker at screening or baseline visit 18. Seated resting systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, or diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg 19. Resting Heart rate less than 45 bpm or greater than 90 bpm at screening or baseline visit 20. Hypersensitivity or history of idiosyncratic reaction to any components or excipients of the investigational or placebo formulation 21. Regular alcohol consumption greater than 14 units per week (1 unit = one half pint beer, 25 mL of 40% spirit or a 125 mL glass of wine) 22. Failure to satisfy the Investigator of fitness to participate for any other reason 23. Active infection 24. History of seizure, whether epileptic, paroxysmal, or of unknown origin 25. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease 26. Any acute illness within 30 days prior to Day 1
Outcome results
None listed