Safety and Pharmacodynamics of SHR-1707 in Alzheimer's Disease Patients

NCT06199037 | Recruiting Phase 2

• 1 other identifier: SHR-1707-201
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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 (1)

• Change from baseline in intracerebral Aβ deposition at Week 26 as assessed by brain Aβ PET

  Week 26

Secondary Outcomes (13)

• 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

Study Arms (2)

SHR-1707

EXPERIMENTAL

Drug: SHR-1707

SHR-1707 placebo

PLACEBO COMPARATOR

Drug: SHR-1707 placebo

Interventions

SHR-1707 DRUG

1 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 injection

SHR-1707

SHR-1707 placebo DRUG

1 cohort of Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease patients will receive SHR-1707 placebo injection

SHR-1707 placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥50 and ≤85 on the date of signing the informed consent, males or females;
• BMI≥18kg/m2 and ≤32 kg/m2, weight ≥45 kg且≤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;
• The score of Hachinski ischemic scale should be ≤4 scores at screening;
• 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 1 months prior to the screening 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;
• 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 \> 160mmHg and diastolic blood pressure \>100mmHg 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 \[Hepatitis B virus surface antigen (HBsAg) positive with HBV DNA \> upper limit of normal\]
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times ULN, or total bilirubin exceeding 2 times ULN

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated hospital of USTC

Hefei, Anhui, 230000, China

RECRUITING

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

Central Study Contacts

Hongyan Qiu

CONTACT

18817821303; hongyan.qiu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1707 compared with placebo

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: February 5, 2024
• Primary Completion: April 30, 2025
• Study Completion (Estimated): June 24, 2026
• Last Updated: April 9, 2024

Record last verified: 2023-12

Locations

CN (1)