A Phase 1, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03017 (NCT06980207) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase 1, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03017
China40 participantsStarted 2025-05
Plain-language summary
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
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
QT interval (QTc) ≥450 ms (Male) or 460 ms (Female) .
* Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.
* Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery…
What they're measuring
1
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)