A Study of SHR-1707 With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

NCT05681819 | Completed Phase 1

• 1 other identifier: SHR-1707-102
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the safety, tolerability and pharmacodynamics of intravenous administration of SHR-1707 In patients with mild cognitive impairment due to Alzheimer's Disease or mild Alzheimer's Disease.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (6)

• To assess the number of patients with adverse events (AEs)

  Week 26

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

  Week 26

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

  Week 26

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

  Week 26

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

  Week 26

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

  Week 26

Secondary Outcomes (8)

• To assess the change from baseline in Brain Amyloid Plaque Deposition as measured by Aβ PET

  Week26/52/78

• To assess the ADA

  Week 26

• To assess the number of patients with adverse events (AEs)

  Week 52/78

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

  Week 52/78

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

  Week 52/78

Study Arms (2)

SHR-1707

EXPERIMENTAL

Up to4 cohorts of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive Multiple-ascending Dose of SHR-1707 injection

Drug: SHR-1707

SHR-1707 placebo

PLACEBO COMPARATOR

Up to 4 cohorts of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive Multiple-ascending Dose of SHR-1707 placebo injection

Drug: SHR-1707 placebo

Interventions

SHR-1707 DRUG

Multiple-ascending Dose

SHR-1707

SHR-1707 placebo DRUG

Multiple-ascending Dose

SHR-1707 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:

• Age ≥ 55 and ≤ 85 on the date of signing the informed consent, males or females;
• BMI ≥ 19 kg/m2 and ≤ 32 kg/m2, weight ≥ 45 kg and ≤ 100 kg at screening or baseline;
• Must meet the diagnostic criteria for MCI due to AD or mild AD;
• The total score of HAMD-17 should be ≤ 10 scores at screening and baseline;
• The score of Hachinski ischemic scale should be ≤ 4 scores at screening and baseline;
• Qualitative amyloid PET scan results from the central laboratory confirmed the presence of pathological changes in AD;
• Agreed to test ApoE genotype;
• Have a stable caregiver; where symptomatic drugs for AD is used, they must be stable for at least 3 months prior to the baseline visit.

You may not qualify if:

• Cognitive impairment of subjects due to other medical or neurological factors (other than AD);
• History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year;
• Any psychiatric diagnosis that may interfere with the subject's cognitive assessment;
• Cannot tolerate MRI or has contraindications to MRI, has significant lesions shown on MRI during screening, or has other conditions that the investigator believes may bring a significant risk to the subject;
• Suspected allergy to Aβ antibody drugs and excipients;
• Patients who had severe trauma or had undergone surgery within 6 months prior to screening, or were scheduled to undergo surgery during the trial;
• History of moderate (3b) or severe renal failure or insufficiency;
• Uncontrolled hypertension: systolic blood pressure \> 160 mmHg and diastolic blood pressure \>100 mmHg in supine position during screening or baseline;
• lead ECG showed QTcF \> 450ms for male and \> 470ms for female during screening;
• History of hypoglycemic coma or uncontrolled diabetes 6 months prior to the screening period;
• Thyroid dysfunction;
• Had unstable or clinically significant cardiovascular disease within 1 year prior to the screening period, had or currently has atrial fibrillation;
• History of malignancy within 5 years prior to screening;
• Patients with clinically significant systemic immunosuppression due to the persistent effects of immunosuppressive drugs;
• Human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody and hepatitis C virus antibody (HCV-Ab) were positive during screening. Hepatitis B active subjects (Hepatitis B virus surface antigen (HBsAg) positive with HBV DNA \> upper limit of normal);

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital Of USTC

Hefei, Anhui, 230001, China

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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1707 injection compared with placebo

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 12, 2023
• Study Start: February 17, 2023
• Primary Completion: May 18, 2024
• Study Completion: August 13, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (1)