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

Bladder Cancer Clinical Trial

Official title: A Phase 1, Two-Part, Open-Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of Single Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers (Part A) and Multiple Ascending Doses of APL-1501 ER Capsules Compared to APL-1202 IR Tablets in Healthy Volunteers (Part B)

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

The study will have 2 parts: Each study part will comprise 2 dosing periods with a 72-hour washout period in between: Period 1: APL-1202 IR tablet dosing and Period 2: APL-1501 ER capsule dosing. In Part A dosing will be single day/single dosing for the APL-1202 IR tablets, and single day/single dosing the APL-1501 ER capsules with 24 participants in 3 sequential cohorts, Cohorts A1, A2, and A3. Each cohort will enrol 8 participants, with male to female participants in a 1:1 ratio. In Period 1/Day 1, participants in all cohorts will be dosed with single dose of 375 mg APL-1202 IR tablets which will followed by a washout period of at least 72 hours, after which participants will be dosed with single dose of APL-1501 ER capsules in Period 2/Day 4, . In Part B dosing will be multi-day/TID dosing for the APL-1202 IR tablets, and multi-day/BID dosing the APL-1501 ER capsules with 24 participants in 2 sequential cohorts, Cohorts B1 and B2. Each cohort will enrol 12 participants, with male to female participants in a 1:1 ratio and in each of the 2 study periods, participants will be administered IP for 5 days. In period 1, participants will administered with APL-1202 IR tablet (TID) on Day 1, Day 2, Day 3, Day 4, and Day 5 and period 2 with APL-1501 ER capsule (BID) dosing on Day 9, Day 10, Day 11, Day 12, and morning of Day 13. ;

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

• NCT number: NCT06034015
• Study type: Interventional
• Source: Jiangsu Yahong Meditech Co., Ltd aka Asieris
• Contact: Qiuyue Qu
• Phone: +86 021 68583863
• Email: qyqu@asieris.cn
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 9, 2023
• Completion date: February 7, 2024