SHR2285 / Jiangsu Hengrui Pharma - LARVOL DELTA

Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty (clinicaltrials.gov) - P2 | N=64 | Terminated | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | N=500 ➔ 64 | Recruiting ➔ Terminated; Adjustment of the sponsor's R&D strategy

Enrollment change • Trial termination • Cardiovascular • Hematological Disorders • Orthopedics • Pain • Thrombosis

The Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, an Oral Small Molecule Factor XIa Inhibitor, in Healthy Chinese Volunteers. (PubMed, Clin Drug Investig) - P1 | "SHR2285 was generally safe and well tolerated in healthy subjects across a wide range of doses. SHR2285 exhibited a predictable pharmacokinetic profile and an exposure-related pharmacodynamic profile."

Journal • PK/PD data

SHR2285, the first selectively oral FXIa inhibitor in China: Safety, tolerability, pharmacokinetics and pharmacodynamics combined with aspirin, clopidogrel or ticagrelor. (PubMed, Front Pharmacol) - P1 | "Purpose: To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR2285, the first oral coagulation factor XIa (FXIa) inhibitor developed in China in combination with aspirin, clopidogrel or ticagrelor in healthy subjects. In group A, group B and group C, the mean maximum inhibition rate of FXI activity was 84.8%, 89.3% and 92.2% and the mean maximum prolongation of APTT was 2.08-fold, 2.36-fold and 2.26-fold, respectively. These data suggest that SHR2285, a potential oral FXIa inhibitor, is expected to become a novel, safe and effective anticoagulant when combined with aspirin, clopidogrel or ticagrelor."

Clinical • Journal • PK/PD data

To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects (clinicaltrials.gov) - P1 | N=52 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Nov 2021 ➔ Jun 2022

Trial completion • Trial completion date • Cardiovascular • Hematological Disorders • Thrombosis

Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty (clinicaltrials.gov) - P2 | N=500 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hematological Disorders • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

First-In-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, a Small-Molecule Factor XIa Inhibitor in Healthy Subjects. (PubMed, Front Pharmacol) - P1 | "This first-in-human study supports the further development of SHR2285 for indications requiring anticoagulation. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03769831, identifier [NCT03769831]."

Clinical • Journal • P1 data • PK/PD data • Cardiovascular • Hematological Disorders • Thrombosis

A Trial of SHR2285 in Healthy Subjects (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Atridia Pty Ltd. | Recruiting ➔ Completed

Trial completion

Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty (clinicaltrials.gov) - P2; N=500; Not yet recruiting; Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

New P2 trial • Cardiovascular • Hematological Disorders • Orthopedics • Pain • Thrombosis • Venous Thromboembolism

To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects (clinicaltrials.gov) - P1; N=52; Active, not recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Cardiovascular • Hematological Disorders • Thrombosis

The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects (clinicaltrials.gov) - P1; N=104; Completed; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • Cardiovascular • Hematological Disorders • Thrombosis

A Trial of SHR2285 in Healthy Subjects (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Atridia Pty Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open

To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects (clinicaltrials.gov) - P1; N=52; Recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hematological Disorders • Thrombosis

To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects (clinicaltrials.gov) - P1; N=52; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Clinical • New P1 trial • Cardiovascular • Hematological Disorders • Thrombosis

The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Completed; N=24 ➔ 36

Clinical • Enrollment change • Trial completion • Thrombosis

The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects (clinicaltrials.gov) - P1; N=104; Recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Recruiting; N=80 ➔ 104; Trial completion date: Sep 2021 ➔ May 2021

Clinical • Enrollment change • Enrollment open • Trial completion date • Cardiovascular • Hematological Disorders • Thrombosis

The PK/PD Study of SHR2285 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=28; Completed; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Not yet recruiting ➔ Completed; N=52 ➔ 28

Clinical • Enrollment change • Trial completion • Cardiovascular • Hematological Disorders • Thrombosis

A Trial of SHR2285 in Healthy Subjects (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Atridia Pty Ltd.

New P1 trial

The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Trial completion date: Jul 2020 ➔ Dec 2020; Initiation date: Jan 2020 ➔ Aug 2020; Trial primary completion date: Apr 2020 ➔ Sep 2020

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Thrombosis

The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects (clinicaltrials.gov) - P1; N=80; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Clinical • New P1 trial • Cardiovascular • Hematological Disorders • Thrombosis

The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Clinical • New P1 trial