None listed
Conditions
Brief summary
This is a double-blind, placebo-controlled, First-In-Human Study of the safety, tolerability, pharmacokinetics of LW-1017 in Healthy Volunteers. Who is it for? You may be eligible for this study if you are aged between 18 to 80 years old and are in good general health without a clinically significant medical history. Study details Healthy volunteers will be randomly assigned to receive single or multiple oral doses of LW-1017 or placebo. Participants will undergo regular safety assessments, including vital signs, blood and urine tests, and other clinical evaluations. The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics of LW-1017 and to identify dose levels suitable for future clinical studies. If results are acceptable, subsequent studies may evaluate LW-1017 in patients with Alzheimer’s disease or Parkinson’s disease.
Interventions
This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics (PK) and pharmacodynamics (PD) of oral doses of LW-1017. The study will be conducted in 2 parts: Part A Single Ascending Dose (SAD) and Part B Multiple Ascending Dose (MAD).
Part A (SAD):
Up to 40 participants will be enrolled in up to 5 cohorts (S1–S5). Each cohort will include up to 8 participants (6 LW-1017; 2 placebo). Participants will receive a single oral dose of LW-101
This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics (PK) and pharmacodynamics (PD) of oral doses of LW-1017. The study will be conducted in 2 parts: Part A Single Ascending Dose (SAD) and Part B Multiple Ascending Dose (MAD). Part A (SAD): Up to 40 participants will be enrolled in up to 5 cohorts (S1–S5). Each cohort will include up to 8 participants (6 LW-1017; 2 placebo). Participants will receive a single oral dose of LW-1017 tablets or matching placebo on Day 1. The starting dose will be 10 mg, with dose escalation up to a maximum of 500 mg. Dose levels for each cohort will be determined by the Safety Review Committee (SRC) based on review of safety and PK data from preceding cohorts. Study drug administration will be supervised by site staff and documented in study records to ensure compliance. Part B (MAD): Up to 40 participants will be enrolled across 5 cohorts (M1–M4 and one healthy elderly cohort). Each cohort will include up to 8 participants (6 LW-1017; 2 placebo). Participants will receive once-daily (QD) oral LW-1017 tablets or matching placebo for 10 consecutive days (Days 1–10; total of 10 doses). The planned starting dose for Cohort M1 is estimated at 50 mg; however, the final starting dose may be adjusted based on review of Part A (SAD) safety and PK data. Subsequent dose levels (up to a protocol-defined maximum dose) will be determined by the Safety Review Committee (SRC) based on safety and PK data from preceding cohorts and the predicted minimum effective dose (MED). A healthy elderly cohort (65–80 years) will commence only after acceptable safety and PK data are observed in younger adults (18–50 years) following at least 5 days of dosing at the same or higher exposure. Study drug administration will be supervised by site staff and documented in study records to ensure adherence and compliance.
Sponsors
Lysoway Therapeutics Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able to provide written informed consent and comply with study requirements. 2. Healthy adult males and females aged 18–55 years (SAD/MAD cohorts); healthy elderly adults aged 65–80 years (elderly cohort, if applicable). 3. Body mass index (BMI) 18.0–32.0 kg/m² and body weight greater than or equal to 45 kg. 4. Medically healthy based on medical history, physical examination, vital signs, ECG, and laboratory tests, without clinically significant abnormalities. 5. Females must be of non-childbearing potential or agree to use highly effective contraception and have negative pregnancy tests prior to dosing. 6. Males must agree to use appropriate contraception and refrain from sperm donation for the protocol-specified period after dosing. 7. Suitable venous access for blood sampling and willingness to comply with study procedures. 8. For MAD cohorts involving CSF collection: willing and medically eligible to undergo lumbar puncture.
Exclusion criteria
1. Known hypersensitivity to the study drug or its components. 2. Clinically significant medical conditions (including cardiovascular, hepatic, renal, neurological, psychiatric, or other systemic diseases) that may interfere with study participation or safety. 3. Significant ECG abnormalities, history of clinically relevant arrhythmia, or risk factors for QT prolongation. 4. Clinically significant laboratory abnormalities, including impaired liver or renal function. 5. History of malignancy within the past 5 years (except adequately treated non-melanoma skin cancer). 6. Clinically relevant immunodeficiency or use of immunosuppressive therapy. 7. Positive screening tests for HIV, hepatitis B, or hepatitis C. 8. Positive drug or alcohol screening at admission. 9. Excessive alcohol consumption or significant tobacco/nicotine use. 10. Pregnant or breastfeeding females. 11. Use of medications or substances that may interact with CYP3A4 or interfere with study assessments within protocol-defined timeframes. 12. Recent participation in another clinical trial, recent blood donation, or recent vaccination within protocol-defined timeframes. 13. Active suicidal ideation or behaviour, or significant psychiatric risk as assessed by C-SSRS or clinical evaluation. 14. Any other condition that, in the opinion of the Investigator, makes the participant unsuitable for the study.
Outcome results
None listed