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

Luye Pharma Group

Status and phase: Not yet enrolling; Phase 1

Conditions: Hallucinations and Delusions Associated With Parkinson Disease Psychosis; Negative Symptoms of Schizophrenia; Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis

Treatments: Drug: LY03017; Drug: LY03017-Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06388551

LY03017/CT-CHN-101

Details and patient eligibility

About

This is a phase 1，randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 < 26.0 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 current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry/ psychology, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results.
• 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 a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial.
• Subject has abnormal vital signs, laboratory abnormalities, and ECGs.
• Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.
• Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust).
• Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results.
• Subject has a history of substance abuse within 1 year or a positive urine drug screen.
• Subject who has daily smoking of ≥ 5 cigarettes within 3 months.
• Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia.
• Subject who has consumption of special diet (such as grapefruit, chocolate, coffee, xanthine-rich foods/drinks) within 48 hours prior to dosing and/or subject who has excessive daily consumption of tea, coffee, grapefruit juice, caffeinated beverages for nearly 3 months.
• Subject who has participated in other clinical trials within 3 months before administration.
• Subject has used blood products or being blood donor or blood loss within 3 months.
• Pregnant, lactating women, or positive pregnancy test.
• Subject who refusal to contraception, or plan to donate sperm or ovums.
• Subject who has a history of needle or blood faintness.
• Subject directly involved in this clinical trial.
• Poor compliance or other conditions which would make participation in the study unsuitable.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

LY03017

Experimental group

Description:

Ascending single oral doses of LY03017 in healthy adult subjects

Treatment:

Drug: LY03017

Placebo

Placebo Comparator group

Description:

LY03017-Placebo

Treatment:

Drug: LY03017-Placebo