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

NCT05367388 | Unknown Phase 1 FDA Drug

• 1 other identifier: APL-101-03
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration versus time curve (AUC)

  Area under the curve (AUC) from time zero to infinity (AUC0-∞) and from time zero to the last quantifiable concentration (AUC0-last)

  Day 1 to Day 14

• Maximum observed plasma concentration

  Maximum observed plasma concentration (Cmax) after dosing of both treatments

  Day 1 to Day 14

Secondary Outcomes (3)

• Time to the maximum observed plasma concentration

  Day 1 to Day 14

• Number of adverse events observed

  Day 1 to Day 20-22

• Apparent plasma terminal elimination half-life

  Day 1 to Day 14

Study Arms (2)

Treatment Sequence A/P

EXPERIMENTAL

Subject will receive a single oral dose (200mg) of Treatment A on Day 1, followed by a 7-day washout period. On Day 8, the subject will begin the second treatment period by receiving a single oral dose (200 mg) of Treatment P.

Drug: APL-101; Drug: PLB-1001

Treatment Sequence P/A

EXPERIMENTAL

Subject will receive a single oral dose (200mg) of Treatment P on Day 1, followed by a 7-day washout period. On Day 8, the subject will begin the second treatment period by receiving a single oral dose (200 mg) of Treatment A.

Drug: APL-101; Drug: PLB-1001

Interventions

APL-101 DRUG

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.

Also known as: Bozitinib, Vebreltinib

Treatment Sequence A/P; Treatment Sequence P/A

PLB-1001 DRUG

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.

Also known as: Bozitinib

Treatment Sequence A/P; Treatment Sequence P/A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be Chinese (1st generation or 2nd generation Chinese with both Chinese parents), or Caucasian.
• Body mass index between 18.0 and 30.0 kg/m2, inclusive.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and at check-in as assessed by the Investigator (or designee). Screening clinical laboratory evaluations may be repeated once at the discretion of the Investigator.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 1.5 × the upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN at screening and check-in. Subjects with ALT or AST \>1.0 × ULN combined with total bilirubin \>1.0 × ULN are excluded.
• QT interval corrected for heart rate using Fridericia's method (QTcF) ≤ 450 msec confirmed by calculating the mean of the triplicate measurements within 4 weeks prior to Day 1.
• Systolic blood pressure between 100 and 140 mmHg or diastolic blood pressure between 50 and 90 mmHg, confirmed by calculating the mean of the triplicate measurements within 4 weeks prior to Day 1.

You may not qualify if:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
• Have positive Coronavirus Disease 2019 (COVID-19) test at screening and/or at check-in, have clinical signs or symptoms of COVID-19 as determined by the Investigator, or have ongoing significant complication(s) from prior COVID-19 infection.
• Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 14 days prior to check in, unless deemed acceptable by the Investigator.
• Have previously completed or withdrawn from this study or any other study investigating APL 101 or similar drug product, and/or have previously received APL 101 or similar drug product.

Sponsors & Collaborators

• Apollomics Inc.: lead

Study Sites (1)

New Zealand Clinical Research

Auckland, New Zealand

RECRUITING

Study Officials

• Marietta Franco, MS

  Apollomics Inc.

  STUDY DIRECTOR

Central Study Contacts

Yufei Chen, MS

CONTACT

650-209-4055; Yufei.Chen@apollomicsinc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The treatment sequence will be determined using a 2×2 crossover design. This study includes an adaptive design feature of variable sample size.

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 10, 2022
• Study Start: May 20, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

NZ (1)