None listed
Conditions
Brief summary
This is a first in human Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic of TP-317 (oral tablets) under fasted conditions in Adult Healthy Volunteers. TP-317 is being developed to address the high unmet medical need for a safe, oral therapy for chronic treatment of mild to moderate inflammatory bowel disease (IBD) This study consists of 3 planned dose cohorts. Each cohort will enroll a total of 8 participants with 6 randomized to TP-317 treatment arm and 2 randomized to the placebo treatment arm. Safety Review Committee will review the participant safety data as needed and determine dose escalation to the next cohort. Participants in the study will be administered oral tablet(s) under fasted conditions, defined as no food or water 10 hours prior to oral dosing.
Interventions
The study consists of 3 planned dose cohorts where each cohort will enrol a total of 8 participants of which 6 randomised to TP-317 treatment arm and 2 randomised to the placebo treatment arm. A total of 24 participants will be enrolled for this study.
The planned dosed cohorts are as follows:
Cohort 1 - Single oral dose of TP-317 10mg or Placebo tablets
Cohort 2- Single oral dose of TP-317 40mg or Placebo tablets
Cohort 3- Single oral dose of TP-317 80mg or Placebo tablets
Participants wi
The study consists of 3 planned dose cohorts where each cohort will enrol a total of 8 participants of which 6 randomised to TP-317 treatment arm and 2 randomised to the placebo treatment arm. A total of 24 participants will be enrolled for this study. The planned dosed cohorts are as follows: Cohort 1 - Single oral dose of TP-317 10mg or Placebo tablets Cohort 2- Single oral dose of TP-317 40mg or Placebo tablets Cohort 3- Single oral dose of TP-317 80mg or Placebo tablets Participants will be administered oral tablet(s) under fasted condition (no food or water 10 hours prior and no food for 4 hours post dose and no water for 2 hours post-dose) on Day 1 . A designated unblinded pharmacist or other qualified personnel at the clinical site will be responsible for administering the study medication Each Cohort will be administered to a distinct group of participants and observed for 24 hours post dose before proceeding with dosing the other planned cohort participants. Safety review committee will determine to proceed with subsequent cohorts after reviewing the safety data.
Sponsors
Thetis Pharmaceuticals LLC
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females aged 18 to 65 years, inclusive at time of signing informed consent form a. Female participants of childbearing potential may participate but are required to either abstain from sexual intercourse or use two highly effective methods of contraception during the study, and for at least 30 days after the last dose of study medication. b. Female participants must not be pregnant or breastfeeding at Screening or during the study period, and for 30 days after the final study drug administration. c. Male participants with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during the study and for at least 90 days after the last dose of study medication. d. Sperm donation is prohibited during the study for at least 90 days and ova donation is prohibited during the study for at least 30 days after the last dose of study medication 2. Must meet the following laboratory criteria during Screening a. Acceptable renal function defined as calculated creatinine clearance 90 mL/min/1.73 m2 or greater by Cockcroft-Gault: b. Neutrophil count within the normal reference range c. Platelet count > 100,000 µl d. Eosinophil count within normal reference range e. basophil count within normal reference range f. Hemoglobin > normal reference range g. PT within normal reference range h. PTT within normal reference range i. Serum creatinine within the normal reference range 3. Body Mass Index of 18 – 35 kg/m2 inclusive 4. Must agree to abstain from tobacco and/or cannabis use from Screening visit through safety follow-up visit. 5. Able to swallow numerous pills (i.e., study medication) at one time or in quick succession. 6. Willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule. 7. Will not participate in another interventional study while in this clinical study.
Exclusion criteria
1. History of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to screening or the participant tests positive at the Screening or upon admission to the CRU for alcohol 2. History of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years (by self-declaration), or a positive toxicology screening panel (urine test including qualitative identification of amphetamines, barbiturates, benzodiazepines, THC, cocaine, and opiates) or positive testing identified by Phase 1-unit standard drug screening panel at Screening Visit or upon admission to study unit 3. Chronic use of cannabis and/or tobacco defined as daily use for greater than 3 months 4. Has greater than 6 months of chronic back pain, Grade 2 or greater, requiring chronic analgesic use, defined as requiring analgesics most days. 5. Any abnormal laboratory test results assessed as clinically significant by the Investigator. 6. Has alkaline phosphatase (ALP), aspartate transaminase (AST) and/or alanine transaminase (ALT) levels or total bilirubin >1.5 × the upper limit of normal (ULN), Participants with a total bilirubin >2 x ULN that have a documented diagnosis of Gilbert’s syndrome may be enrolled 7. History or presence of any form of cancer within the 5 years prior to screening, with the exception of excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ such as cervical or breast carcinoma that has been excised or resected completely and is without evidence of local recurrence or metastasis. 8. Has any medical condition (acute or chronic illness) or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant’s ability to participate in this study such as but not limited to: Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease. Presence or history of any significant hemorrhage, thromboembolic diseases or diatheses such as hypercoagulability, platelet disorder, or erythrocytosis. 9. Any surgical procedure (except for procedures determined by the investigator to be minor) within 4 weeks prior to the Screening Visit 10. Use of concomitant medication (including over the counter medication, health supplements, multivitamins and vitamin C, vitamin and omega-3 supplements, and herbal remedies such as St. John’s Wort extract) must be stopped at least 14 days prior to the first dose and not restarted until Day 7 11. Unable to stop use of proton pump inhibitors, H2 -receptor antagonists and antacids for 14 days prior to study drug administration through 7 days post study drug administration 12. Received a live vaccine within 4 weeks prior to Screening visit. 13. Know hypersensitivity to the study drug or it’s excipients thereof, or drug or other allergy that, in the opinion of the Investigator contraindicates participation in the study. 14. Intake of more than 6 cups of coffee or tea or equivalent of caffeinated beverages per day for > 3 months. 15. Positive test for hepatitis B virus (HBsAg), hepatitis C virus (HCV) antibodies, HIV1 or HIV2 at Screening Visit (participants testing positive for Hep B that have been treated be enrolled at investigator discretion) 16. Cannot have donated blood (quantified by 10% of participant’s anticipated blood volume) or had a blood transfusion within 3 months prior to study drug administration. 17. An active infection within 2 weeks of admission to CRU, determined by the investigator to be clinically significant. 18. Participation in any other study involving an investigational product within the last 30 days or 5 half-lives, whichever is greater, prior to the Screening Visit or during the study
Outcome results
None listed