None listed
Conditions
Brief summary
This is a two-part, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RT-312 following single (Part 1) and multiple (Part 2) ascending dose administration in healthy participants. Part 1 will also explore the effect of food on a single oral dose of RT-312 (Food Effect cohort). Up to 80 participants between 18 and 45 years of age at the time of providing informed consent, will be enrolled in this study across the two parts. RT-312 or placebo will be administered as an oral tablet.
Interventions
This is a two-part, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RT-312 following single (Part 1) and multiple (Part 2) ascending dose administration in healthy participants. Part 1 will also explore the effect of food on a single oral dose of RT-312 (Food Effect cohort). Up to 80 participants between 18 and 45 years of age at the time of providing informed consent, will be enrolled in this stud
This is a two-part, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RT-312 following single (Part 1) and multiple (Part 2) ascending dose administration in healthy participants. Part 1 will also explore the effect of food on a single oral dose of RT-312 (Food Effect cohort). Up to 80 participants between 18 and 45 years of age at the time of providing informed consent, will be enrolled in this study across the two parts. RT-312 will be administered as an oral tablet (yellow, film-coated, immediate release tablet in 10 mg or 30 mg strength). Placebo will be administered as an oral (lactose monohydrate and microcellulose) tablet, matched in appearance to RT-312. There will be up to 7 groups (cohorts) of 8 participants (2 placebo and 6 active per cohort) in Part 1 of the study, with planned doses of 10 mg, 30 mg, 60 mg, 90 mg, 120 mg, 180 mg, and 240 mg of RT-312 or placebo administered once. One Part 1 cohort (planned at 90 mg) will receive a second dose of RT-312 or placebo administered with a standard breakfast at least 7 days after the first dose. Breakfast will be provided by the research team and may be comprised of toast, bacon, eggs, or similar items. There will be up to 3 cohorts of 8 participants (2 placebo and 6 active per cohort) in Part 2 of the study, with planned doses of 60 mg, 90 mg, and 120 mg of RT-312 or placebo administered once daily for 7 days. Dose levels may be adjusted by the Safety Review Committee depending on emerging data from earlier cohorts. Adherence to the intervention protocol will be confirmed via mouth checks and documentation by site personnel dispensing and administering the investigational product.
Sponsors
Retex AU Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
- Healthy male or female participants, between the ages of 18 and 45 years inclusive, at the time of signing the informed consent - Medically healthy (in the opinion of the Investigator or delegate), as determined by pre-study medical history, and without clinically significant abnormalities in physical examination, vital signs, ECG or laboratory safety tests - Body weight within 50 to 120 kg (inclusive) and BMI within the range 18 to 32 kg/m2 (inclusive) - Willing and able to adhere to study restrictions, including contraception requirements
Exclusion criteria
- Evidence or clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, malignancies, or drug hypersensitivity as determined by the Investigator. Includes genetic immunodeficiency or family history of genetic immunodeficiency, dysphagia or any history of gastrointestinal diseases that affect drug absorption or have undergone operations that affect drug absorption - Recent hospital admission or major surgery within 3 months prior to Screening, or elective surgery within 4 weeks prior to study intervention administration - Any history of organ or bone marrow transplant - History of prescription or illicit drug abuse or alcohol abuse within 6 months prior to Screening, or positive alcohol or drug test at Screening or admission - Evidence of SARS-CoV-2 infection at time of Screening or admission - Positive serology test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C - Major clinical infections or active infection with herpes simplex, herpes zoster, or varicella within 3 months prior to Screening, or any symptoms of infection (excluding foot fungal infection) within 7 days prior to Screening - Donated or lost >500 ml of blood in the previous 30 days prior to Screening - Any condition or finding that in the opinion of the Investigator or designee would put the individual or study conduct at risk if the individual were to participate in the study - Any liver function panel analyte value above upper limit of normal - Taken any prescription medications (excluding contraceptives) within 14 days or 5 half-lives (whichever is longer) of the first dose of study intervention. - Received live vaccines or attenuated vaccines within 1 month before dosing. - Used over the counter (OTC) medication, herbal medication and dietary supplements (including St John’s Wort) within 7 days or 5 half-lives prior to dosing, whichever is later. Occasional paracetamol (up to 1000 mg per day) is allowed until time of admission - Received any other experimental therapy including device or an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to first study intervention administration - Inability to attend all the study visits or comply with study procedures (including smoking, caffeine, and dietary restrictions during admission)
Outcome results
None listed