Randomized crossover study of PG511/PG521/PG531 versus PG203 in healthy volunteers: safety, tolerability, PK for schizophrenia & levodopa‑induced dyskinesia

The trial enrolled healthy volunteers of both sexes; inclusion of females and males was permitted. Participants were classified as healthy and were not required to have a specific medical diagnosis, although the study targeted interventions relevant to schizophrenia and levodopa‑induced dyskinesia in Parkinson’s disease. The age range was indicated by code “3”, which was not further defined in the provided data. The sponsor did not provide the total number of enrolled subjects. Selection criteria required participants to be free of significant medical comorbidities and to refrain from concomitant use of medications that could interfere with study assessments; lifestyle factors such as diet, physical activity, and smoking were not specified.

The study is a phase 2, randomized, double‑blind, placebo‑controlled trial evaluating the safety and pharmacologic profile of the investigational agents PG511, PG521, and PG531 compared with PG203 in healthy volunteers, with recruitment planned from 30 June 2026 to 31 December 2026 and each participant remaining in the study for approximately eight weeks. After informed consent, a screening visit confirms eligibility, followed by a baseline visit where participants are randomly assigned to receive either an investigational drug or PG203 in a blinded fashion; subsequent follow‑up visits are scheduled at weeks 2, 4, and 6 to collect vital signs, laboratory data, and adverse‑event information, and an end‑of‑study visit at week 8 completes safety assessments and study‑drug discontinuation. The investigational agents are intended for the treatment of psychotic disorders such as schizophrenia and levodopa‑induced dyskinesia in Parkinson’s disease. Early termination may occur if a participant experiences a serious adverse event, violates protocol requirements, requires prohibited concomitant medication, or withdraws consent, at which point data collection for that individual ceases while the trial continues for remaining subjects.

The source data does not contain any information regarding experimental medication, pharmaceutical form, dosage, route of administration, frequency, or any non‑experimental treatments such as standard‑of‑care therapy, placebo, or comparator agents. Consequently, no treatment description can be provided based on the available data.

Efficacy will be assessed according to the predefined primary and secondary endpoints established in the study protocol, with measurements conducted at scheduled visits throughout the trial.