A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in… (NCT05238701) | Clinical Trial Compass
CompletedPhase 1
A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in Healthy Subjects
China104 participantsStarted 2022-02-25
Plain-language summary
This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for subsequent clinical trials.
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 to 45 years;
✓. Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 \~ 28.0 kg/m2, inclusive;
✓. 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, 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 self-mutilation; or at risk of suicide;
✕. 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;