This is a phase 1，randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects
Subject who voluntarily participate and sign the informed consent form.
Healthy male/female volunteers aged ≥18 and ≤ 45 years.
Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and < 28.0 kg/m2.
Able to comply with the lifestyle restrictions.
Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.
Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders.
Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.
Subject has clinically significant abnormalities in vital signs, laboratory tests, and ECGs, such as Pulse < 55 beats/min or > 100 beats/min, Systolic blood pressure < 90 mmHg or ≥140 mmHg, Diastolic blood pressure < 60 mmHg or ≥90 mmHg.
Sequential
LY03017
Drugadministered orally
LY03017-Placebo
Drugadministered orally
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Maximum observed concentration at steady state (Cmax,ss) of LPM526000133 in plasma
Time to maximum observed concentration at steady state (Tmax,ss) of LPM526000133 in plasma
Minimum observed concentration at steady state (Cmin,ss) of LPM526000133 in plasma
Area Under the Concentration-Time Curve from Time Zero to Tau over a Dosing Interval at Steady State(AUC0-τ,ss）of LPM526000133 in plasma
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This trial is not recruiting at the moment. You can still explore other options:
