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Completed

NCT Number: NCT06114745

A Trial of SHR-1707 Infusion 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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Liverpool Hospital, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Exclusion criteria related to previous or concomitant diseases, as listed in the protocol.
  • Exclusion criteria related to general or laboratory tests, as listed in the protocol.
  • 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.

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.

  • 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.

Treatment and study plan

SHR-1707 injection

Drug

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

Placebo

Drug

Placebo will be administered through IV infusion

Primary outcomes

  1. Adverse events(AEs)

    Time frame: week 26

    To assess the number of patients with adverse events

  2. Baseline in vital signs value

    Time frame: week 26

    To assess the number of patients with clinically significant change from baseline in vital signs value

  3. Physical examination

    Time frame: week 26

    To assess the number of patients with clinically significant change in physical examination

  4. Laboratory examination

    Time frame: week 26

    To assess the number of patients with clinically significant change from baseline in laboratory examination

  5. Baseline in 12-ECG values

    Time frame: week 26

    To assess the number of patients with clinically significant change from baseline in 12-ECG values

  6. MRI

    Time frame: week 26

    To assess the number of patients with clinically significant change in brain MRI (cerebral edema, microbleeding, etc.)

Secondary outcomes

  1. Aβ positron emission tomography (PET)

    Time frame: week 26

    To assess the change from baseline in intracerebral Aβ deposition as measured by brain Aβ positron emission tomography (PET)

  2. Concentrations of SHR-1707

    Time frame: week 26

    To assess concentrations of SHR-1707 after multiple doses of administration

  3. Anti-Drug antibody

    Time frame: week 26

    To assess the incidence and time of occurrence of anti-SHR-1707 antibodies

Sponsors and collaborators

Lead sponsor

Atridia Pty Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 2, 2023
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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