drugset / Trial / NCT05367388

A Study Comparing Two Different Capsules, APL-101 and PLB-1001 Capsules, in Healthy Chinese and Caucasian Participants

NCT05367388

Phase 1 Unknown 48 enrolled Apollomics Inc.
RandomizedCrossoverOpen-labelBasic science

Summary

This is a Phase 1, open-label, multi-center, randomized, 2-period, adaptive design, crossover study to assess the bioequivalence of APL-101 (Vebreltinib) capsules and PLB-1001 (Bozitinib) capsules. The treatments to be administered orally in this study include: * Treatment A (reference): Two 100 mg APL-101 (Vebreltinib) capsules (200 mg dose), manufactured for Apollomics, Inc * Treatment P (test): Two 100 mg PLB-1001 (Bozitinib) capsules (200 mg dose), manufactured for Beijing Pearl Biotechnology Co., Ltd. APL-101 capsules (Treatment A) and PLB-1001 capsules (Treatment P) are similar drug products.

Timeline

Start
2022-05-20
Primary completion
2022-11
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Vebreltinib Small molecule 200 mg Oral

Indications

No indication recorded.