A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of Orally Administered PRN1008
- Conditions
- Healthy VolunteersInflammatory and Immune System - Autoimmune diseases
- Registration Number
- ACTRN12614000359639
- Lead Sponsor
- Clinical Network Services (CNS) Pty Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 108
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).
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of single and multiple doses of PRN1008 when administered to healthy adult participants. Specific assessments to evaluate treatment safety include the following: the frequency and type of adverse events, clinical laboratory testing, 12-lead ECGs and vital signs.[For SAD Part A Up to 8 (+/-1) days after dosing <br>For MAD Part B Up to 17 days (+/-2) days after dosing]
- Secondary Outcome Measures
Name Time Method