STSA-1002 / Staidson Biopharma - LARVOL DELTA

To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome (clinicaltrials.gov) - P3 | N=406 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

To Evaluate The Safety and Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome (clinicaltrials.gov) - P3 | N=406 | Not yet recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

New P3 trial • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

Preclinical evaluation of STSA-1002, a novel human and rhesus monkeys cross-reactive monoclonal antibody targeting C5a, in acute respiratory distress syndrome models. (PubMed, Int Immunopharmacol) - "These results furnish comprehensive preclinical evidence for STSA-1002 as an innovative anti-C5a therapeutic agent and provide a preliminary rationale for developing immunomodulatory therapy in ARDS."

Journal • Preclinical • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Oncology • Pulmonary Disease • Respiratory Diseases • CCL2 • CSF2 • IL1B • IL6 • ITGAM • TNFA

To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome (clinicaltrials.gov) - P1/2 | N=47 | Completed | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Recruiting ➔ Completed | Trial completion date: Sep 2026 ➔ Apr 2025 | Trial primary completion date: Aug 2025 ➔ Mar 2025

Trial completion • Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

To Evaluate the Safety and Initial Efficacy of STSA-1002 Injection in Patients with Acute Respiratory Distress Syndrome (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | N=90 ➔ 60

Enrollment change • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects (clinicaltrials.gov) - P1 | N=50 | Terminated | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Trial completion date: Aug 2024 ➔ Mar 2024 | Recruiting ➔ Terminated; Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.

Trial completion date • Trial termination

A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Trial completion date: Dec 2023 ➔ Aug 2024 | Trial primary completion date: Sep 2023 ➔ Aug 2024

Trial completion date • Trial primary completion date

To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2023 ➔ Dec 2023

Enrollment open • Trial initiation date • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome (clinicaltrials.gov) - P1/2 | N=90 | Not yet recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

New P1/2 trial • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

The Safety and Tolerability of STSA-1002 Following Subcutaneous Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Recruiting ➔ Completed

Trial completion • ANCA Vasculitis • Vasculitis

The Safety of STSA-1002 Following Intravenous Infusion in Healthy Subjects (clinicaltrials.gov) - P1 | N=52 | Completed | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Recruiting ➔ Completed | Trial completion date: Jul 2022 ➔ Jan 2023 | Trial primary completion date: Jul 2022 ➔ Jan 2023

Trial completion • Trial completion date • Trial primary completion date • CXCL8 • IL6

A Study of STSA-1002 in Healthy Subjects (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Recruiting ➔ Completed

Trial completion • CXCR1 • MPO

The Safety and Tolerability of STSA-1002 Following Subcutaneous Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Vasculitis

The Safety and Tolerability of STSA-1002 Following Subcutaneous Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

New P1 trial • Vasculitis

A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • CSF2 • CXCL8 • IL10 • IL2 • IL6

A Study of STSA-1002 in Healthy Subjects (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • CXCR1 • MPO

A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

New P1 trial • CSF2 • CXCL8 • IL10 • IL2 • IL6

A Study of STSA-1002 in Healthy Subjects (clinicaltrials.gov) - P1 | N=26 | Not yet recruiting | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

New P1 trial • CXCR1 • MPO

The Safety and Tolerability of STSA-1002 Following Intravenous Infusion in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd | Recruiting ➔ Completed

Trial completion • CXCL8 • IFNG • IL6 • TNFA

The Safety of STSA-1002 Following Intravenous Infusion in Healthy Subjects (clinicaltrials.gov) - P1; N=52; Recruiting; Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CXCL8 • IFNG • IL6 • TNFA

The Safety of STSA-1002 Following Intravenous Infusion in Healthy Subjects (clinicaltrials.gov) - P1; N=52; Not yet recruiting; Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

Clinical • New P1 trial • CXCL8 • IFNG • IL6 • TNFA