A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLuye Pharma Group Ltd.
About this trial
This is a randomized, double-blind, placebo-controlled, ascending multiple oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects and/or subjects with stable schizophrenia.
Eligibility criteria
Qualifiers
Subjects sign informed consent voluntarily.
Male or female aged 18 to 45 years.
Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2 Subjects with Stable Schizophrenia
Subjects themselves and / or their guardians sign informed consent voluntarily.
Disqualifiers
Subjects have any clinically significant medical condition or chronic disease.
Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.
Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.
Subjects with a history of orthostatic hypotension or syncope.
Trial design
Treatments tested in this trial
- LY03020
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov