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

NCT05367388 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-06-15

No results posted yet for this study

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.

Conditions

  • Bioequivalence

Interventions

DRUG

APL-101

APL-101 (Vebreltinib) is an orally available small molecule, which is a tyrosine kinase inhibitor (TKI) for the mesenchymal epithelial transition protein tyrosine kinase receptor (c-Met) with high selectivity and potency. The treatments to be administered in this study include: • Treatment A (reference): Two 100 mg APL-101 (Vebreltinib) capsules (200 mg dose), manufactured for Apollomics, Inc.

DRUG

PLB-1001

PLB-1001 (Bozitinib) is a chemical drug category 1.1 innovative drug. It is a highly effective and highly selective c-Met tyrosine kinase inhibitor. The treatments to be administered in this study include: • Treatment P (test): Two 100 mg PLB-1001 (Bozitinib) capsules (200 mg dose), manufactured for Beijing Pearl Biotechnology Co., Ltd.

Sponsors & Collaborators

  • Apollomics Inc.

    lead INDUSTRY

Principal Investigators

  • Marietta Franco, MS · Apollomics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2022-11-30
Completion
2022-12-31
FDA Drug
Yes

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05367388 on ClinicalTrials.gov