drugset / Trial / NCT06034015

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers

NCT06034015

Phase 1 Unknown 48 enrolled Jiangsu Yahong Meditech Co., Ltd aka Asieris
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an integrated Phase 1, single centre, 2-part, open-label, dose-escalation study conducted in healthy volunteers to assess the safety, tolerability, and PK of APL-1501 ER capsules in comparison to APL-1202 IR tablets.

Timeline

Start
2023-09-09
Primary completion
2024-01-19
Completion
2024-02-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator APL-1202 Unknown 375 mg Oral
Comparator APL-1501 Unknown 764 mg
Comparator APL-1501 Unknown 1146 mg
Comparator APL-1501 Unknown 1528 mg