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

NCT06114745 | Completed Phase 1

• 1 other identifier: SHR-1707-103
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Alzheimer's Disease (AD)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Aβ positron emission tomography (PET)

  week 26

• Concentrations of SHR-1707

  week 26

• Anti-Drug antibody

  week 26

Study Arms (2)

Dose level 1 SHR-1707

EXPERIMENTAL

SHR-1707 is administered intravenously.

Drug: SHR-1707 injection

Dose level 1 Placebo

PLACEBO COMPARATOR

Placebo is administered intravenously.

Drug: Placebo

Interventions

SHR-1707 injection DRUG

Drug: SHR-1707 SHR-1707 will be administered through IV infusion. Drug: Placebo Placebo will be administered through IV infusion

Dose level 1 SHR-1707

Placebo DRUG

Placebo will be administered through IV infusion

Dose level 1 Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive impairment due to other medical or neurological factors (non-AD).
• History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past 1 year.
• Any psychiatric diagnosis that may interfere with the subject's cognitive assessment.
• Inability to tolerate MRI examination or have contraindications to MRI examination.
• \. The subject is suicidal according to the investigator's judgment or has committed suicidal behaviour within 6 months prior to the screening period.
• \. Severe visual or hearing impairment, unable to cooperate in the scale examination.
• \. Patients suspected to be allergic to Aβ antibody drugs and their excipients.
• \. Women who are pregnant, or women of childbearing age with positive pregnancy test results or are lactating.
• \. History of drug abuse and/or drug addiction within 1 year prior to screening.
• Use of dual antiplatelet or anticoagulant drugs within 3 months prior to the randomization period or planned during the trial.
• Have had prior treatment with an anti-amyloid immunotherapy within 1 year prior to randomization.
• \. Those who have participated in a clinical trial of any drug or medical device within 3 months prior to screening.
• \. Investigators and site-related personnel or other persons directly involved in the implementation of the protocol.
• \. Other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (3)

Liverpool Hospital

Sydney, New South Wales, Australia

Location

Southern Neurology

Sydney, New South Wales, Australia

Location

Austin Health

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1707 injection compared with placebo

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: November 2, 2023
• Study Start: April 17, 2024
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)