None listed
Conditions
Brief summary
Alzheimer’s disease is the most common cause of dementia in older adults and affects millions of people in Australia and worldwide. Alzheimer’s disease causes loss of memory, difficulty in thought and reasoning, and behavioural changes. There are currently no effective treatments that slow or stop the progression of Alzheimer’s disease. In an effort to address the need for medications that treat Alzheimer’s disease, Samumed, LCC (the sponsor) has developed a new investigational drug, SM07883. SM07883 is a novel small molecule inhibitor of DYRK1a which has been tested in a number of non-clinical studies. This study is a first-in-human, single dose, dose-escalation safety study in healthy subjects 18-70 years old. Subjects who provide written informed consent for this study will undergo baseline evaluations at the Screening visit. Subjects will participate in a screening period of up to 21 days and a 28-day observation period. Sequential dose cohorts of healthy subjects will receive a single fixed dose of SM07883 at 5, 10, 15, 30, 60, 120 and 180 mg. Each cohort will consist of 4-6 subjects. Safety data from each cohort will be reviewed by a Safety Review Committee prior to continuing to the next cohort. The purpose of this study is to learn more about the safety of SM07883, how well it is tolerated, and what happens to it in the body when given as a single dose oral tablet to healthy subjects. The findings from this study will support future studies in Alzheimer’s patients.
Interventions
This Phase I study is a first-in-human, single dose, dose escalation safety study in healthy volunteers. Participants will be administered SM07883 orally as a single dose.
Sequential dose cohorts of healthy participants will receive a single fixed dose of SM07883 at 5, 10, 15, 30, 60, 120, or 180 mg followed by a 28-day observation period.
Safety data for each cohort will be reviewed by the Safety Review Committee (SRC) prior to escalation to the next cohort.
Sponsors
Samumed Pacific Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult females 18 to 70 years old; or, healthy adult males 18 to 70 years old, who are surgically sterile; or, healthy adult males greater than 55 years old with no interest in fathering a child in the future 2. Body mass index (BMI) of 19 to 30, inclusive 3. Subject must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed. 4. Willingness and ability to comply with all scheduled study visits, laboratory tests, contraception requirements, and other study procedures. 5. Willing to avoid extensive sun exposure, phototherapy, or use of a tanning salon for the duration of the study.
Exclusion criteria
1. Women who are pregnant, lactating, or have a positive or indeterminate pregnancy result 2. Women of childbearing potential who are sexually active, and who are not willing to use an acceptable method of birth control during the study period 3. Men up to 55 years old (inclusive) who are of childbearing potential 4. Men greater than 55 years old of childbearing potential who may wish to father a child in the future 5. Men greater than 55 years old of childbearing potential who are sexually active and have a partner who is capable of becoming pregnant, neither of whom are agreeable to using an acceptable method of birth control 6. History of or current allergy to investigational product ingredients. 7. Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, musculoskeletal, immunologic, neurologic, or dermatologic disease 8. History of malignancy within the last 5 years 9. Recent treatment with an investigational product. 10. History of long QT syndrome and/or clinically significant ECG 11. History of clinically significant increased intracranial pressure, bleeding diathesis, cardiopulmonary instability, or soft tissue infection at the proposed puncture site 12. Clinically significant laboratory abnormalities at Screening 13. Recent active infection or febrile illness 14. Recent serious illness requiring hospitalization 15. Any chronic condition that has not been well controlled. 16. Uncontrolled hypertension 17. Regular alcohol abuse 18. A history of abuse of prescription or illicit drugs 19. Positive urine drug screen 20. Recent use of strong inhibitors or inducers of CYP3A4 and CYP2D6 enzymes (eg grapefruit, grapefruit juice, and star fruit). 21. Subjects who have a current or pending disability claim, workers’ compensation, or litigation(s) 22. Subjects who are immediate family members of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site. 23. Subjects employed by Samumed Pacific Pty Ltd, or any of its affiliates or development partners responsible for the conduct of the study
Outcome results
None listed