APL-1501 / Asieris - LARVOL DELTA

YHGT-APL1501-NHS-103: A Study of APL-1501 Extended Release Capsules Compared to APL-1202 Immediate Release Tablets in Healthy Volunteers (clinicaltrials.gov) - P1 | N=12 | Terminated | Sponsor: Syneos Health | N=32 ➔ 12 | Trial completion date: Oct 2024 ➔ Jul 2024 | Not yet recruiting ➔ Terminated; Study terminated by sponsor due a business decision and development strategy.

Enrollment change • Trial completion date • Trial termination

A Study of APL-1501 Extended Release Capsules Compared to APL-1202 Immediate Release Tablets in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Syneos Health

New P1 trial

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 (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Jiangsu Yahong Meditech Co., Ltd aka Asieris

New P1 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Phase I, Two-phase, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APL-1501 ER Tablets (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: Asieris Pharmaceuticals (AUS) Pty Ltd.; Not yet recruiting ➔ Completed; Trial completion date: Jun 2021 ➔ Feb 2021; Trial primary completion date: Apr 2021 ➔ Dec 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Phase I, Two-phase, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APL-1501 ER Tablets (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Asieris Pharmaceuticals (AUS) Pty Ltd.

Clinical • New P1 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Asieris' APL-1501 Approved for Phase I Clinical Trial in Australia (PRNewswire) - "Asieris Pharmaceuticals...announced that Australian regulatory authorities have approved its Phase I clinical trial of APL-1501. The objective of this Phase I study is to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of APL-1501...'The approval of APL-1501 clinical trial in Australia is another important milestone on the journey of Asieris' international clinical development'."

New P1 trial • Non-US regulatory • Oncology