A Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of SHR-1707 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1707 in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD for 26 weeks.

Study Overview

• Status: Not yet recruiting
• Conditions: Alzheimer's Disease (AD)
• Intervention / Treatment: Drug: Placebo; Drug: SHR-1707 injection

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kathy You; Phone Number: +61 02 9299 0433; Email: kathyyou@atridia.com
• Study Contact Backup: Name: Ravi Patel; Phone Number: +61 0452363506; Email: ravi.patel@atridia.com

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • Liverpool Hospital
    • Sydney, New South Wales, Australia
      • Southern Neurology
      • Contact: Raymond Schwartz
  • Victoria
    • Melbourne, Victoria, Australia
      • Austin Health
      • Contact: Henry Zeimer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
2. Male or female aged between 55 years and 85 years (inclusive) at the date of signed consent form.
3. Total body weight of 45~100 kg (inclusive), with a body mass index (BMI) of 19~32 kg/m2 (inclusive)at screening or baseline.
4. The subjects must meet the following clinical criteria for Mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or criteria for mild AD.
5. The subjects should have a stable caregiver who will help the patients to participate in the whole study process.

Exclusion Criteria:

1. Cognitive impairment due to other medical or neurological factors (non-AD).
2. History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past 1 year.
3. Any psychiatric diagnosis that may interfere with the subject's cognitive assessment.
4. Inability to tolerate MRI examination or have contraindications to MRI examination.

6. Exclusion criteria related to previous or concomitant diseases, as listed in the protocol.

7. Exclusion criteria related to general or laboratory tests, as listed in the protocol.

8. The subject is suicidal according to the investigator's judgment or has committed suicidal behaviour within 6 months prior to the screening period.

9. Severe visual or hearing impairment, unable to cooperate in the scale examination.

10. Patients suspected to be allergic to Aβ antibody drugs and their excipients.

11. Women who are pregnant, or women of childbearing age with positive pregnancy test results or are lactating.

12. History of drug abuse and/or drug addiction within 1 year prior to screening.

13 Use of dual antiplatelet or anticoagulant drugs within 3 months prior to the randomization period or planned during the trial.

14.Have had prior treatment with an anti-amyloid immunotherapy within 1 year prior to randomization.

15. Those who have participated in a clinical trial of any drug or medical device within 3 months prior to screening.

16. Investigators and site-related personnel or other persons directly involved in the implementation of the protocol.

17. Other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose level 1 SHR-1707; SHR-1707 is administered intravenously.	Drug: SHR-1707 injection; Drug: SHR-1707 SHR-1707 will be administered through IV infusion. Drug: Placebo Placebo will be administered through IV infusion
Placebo Comparator: Dose level 1 Placebo; Placebo is administered intravenously.	Drug: Placebo; Placebo will be administered through IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events(AEs)	To assess the number of patients with adverse events	week 26
Baseline in vital signs value	To assess the number of patients with clinically significant change from baseline in vital signs value	week 26
Physical examination	To assess the number of patients with clinically significant change in physical examination	week 26
Laboratory examination	To assess the number of patients with clinically significant change from baseline in laboratory examination	week 26
Baseline in 12-ECG values	To assess the number of patients with clinically significant change from baseline in 12-ECG values	week 26
MRI	To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)	week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aβ positron emission tomography (PET)	To assess the change from baseline in intracerebral Aβ deposition as measured by brain Aβ positron emission tomography (PET)	week 26
Concentrations of SHR-1707	To assess concentrations of SHR-1707 after multiple doses of administration	week 26
Anti-Drug antibody	To assess the incidence and time of occurrence of anti-SHR-1707 antibodies	week 26

Collaborators and Investigators

• Sponsor: Atridia Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 17, 2024
• Primary Completion (Estimated): November 7, 2025
• Study Completion (Estimated): November 7, 2025

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 28, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: SHR-1707-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No