SHR-1707 / Jiangsu Hengrui Pharma - LARVOL DELTA

A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease (clinicaltrials.gov) - P1 | N=2 | Completed | Sponsor: Atridia Pty Ltd. | Active, not recruiting ➔ Completed | N=12 ➔ 2 | Trial completion date: Nov 2025 ➔ Jul 2025 | Trial primary completion date: Nov 2025 ➔ Jul 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Safety, Tolerability and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients. (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • APOE

Safety, Tolerability and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients. (clinicaltrials.gov) - P1 | N=33 | Active, not recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2025 ➔ May 2024

Enrollment closed • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • APOE

A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Atridia Pty Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, single-ascending-dose, phase 1 studies. (PubMed, Alzheimers Res Ther) - P1 | "A single intravenous dose of SHR-1707 at 2-60 mg/kg was safe and well tolerated in healthy young adult and elderly subjects. The PK and PD profiles are supportive for further clinical development."

Clinical • Journal • P1 data • PK/PD data • Alzheimer's Disease • CNS Disorders • Fatigue • Aβ42

A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Atridia Pty Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Safety and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Atridia Pty Ltd. | Phase classification: P1b ➔ P1

Phase classification • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Safety and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

New P2 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease (clinicaltrials.gov) - P1b | N=16 | Not yet recruiting | Sponsor: Atridia Pty Ltd.

New P1 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, phase 1 studies (AAIC 2023) - P1 | "A single intravenous dose of SHR-1707 at 2-60 mg/kg was safe and well tolerated in healthy young adult and elderly subjects. The PK/PD profiles are supportive of further clinical development."

Clinical • P1 data • PK/PD data • Alzheimer's Disease • Fatigue • Aβ42

A randomized, double-blind, placebo-controlled phase 1b study to evaluate the safety, tolerability, and pharmacodynamics of an anti-amyloid-β antibody SHR-1707 in patients with mild cognitive impairment and mild Alzheimer's disease (AAIC 2023) - P1 | "Pharmacodynamic studies in vitro showed that SHR-1707 is more potent than lecanemab. Topline results are expected in Q1 2024. Conclusion : This trial will obtain safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical efficacy data of SHR-1707 to support advancement to confirmatory phase 2 or 3 studies in patients with MCI due to AD and mild AD."

Clinical • P1 data • PK/PD data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • APOE

A Study of SHR-1707 in Healthy Young Adult and Elderly Subjects (clinicaltrials.gov) - P1 | N=63 | Completed | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders

Safety, Tolerability and Pharmacodynamics of SHR-1707 in Alzheimer’s Disease Patients. (clinicaltrials.gov) - P1 | N=41 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • APOE

Safety, Tolerability and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients. (clinicaltrials.gov) - P1 | N=41 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

New P1 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • APOE

A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: Atridia Pty Ltd. | Recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders

A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects (clinicaltrials.gov) - P1; N=62; Recruiting; Sponsor: Atridia Pty Ltd.; Trial completion date: Dec 2022 ➔ May 2022; Trial primary completion date: Oct 2022 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

A Study of SHR-1707 in Healthy Young Adult and Elderly Subjects (clinicaltrials.gov) - P1; N=62; Recruiting; Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Clinical • New P1 trial • Alzheimer's Disease • CNS Disorders • Plasma Aβ40 • Plasma Aβ42

A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects (clinicaltrials.gov) - P1; N=62; Recruiting; Sponsor: Atridia Pty Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Alzheimer's Disease • CNS Disorders

A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects (clinicaltrials.gov) - P1; N=62; Not yet recruiting; Sponsor: Atridia Pty Ltd.

Clinical • New P1 trial • Alzheimer's Disease • CNS Disorders