A Phase 1, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03017

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorLuye Pharma Group Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • LY03017
  • LY03017-Placebo

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators