A Study of QLH2405 in Healthy Participants and Participants With Mild Cognitive Impairment Due to… (NCT07489599) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of QLH2405 in Healthy Participants and Participants With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
68 participantsStarted 2026-03
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of QLH2405 injection in healthy participants and participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild Alzheimer's disease.
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Voluntarily participate and sign the informed consent.
✓. Male or female, aged 18 to 65 years (inclusive).
✓. Healthy status as confirmed by medical evaluation.
✓. Body mass index (BMI) of 19-28 kg/m² (inclusive).
✓. Agree to use effective contraception and have no plans for sperm/egg donation or pregnancy from ICF signing until 9 months post-dose.
✓. Voluntarily participate and sign the informed consent, able to communicate well with the investigator and complete the trial per protocol.
✓. Male or female, aged 50 to 85 years (inclusive).
✓. A diagnosis of mild MCI due to AD or mild AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.
Exclusion criteria
✕. History of significant diseases, or any existing disease may affect the study or pose an unacceptable risk to the participant.
✕. Positive for HBsAg, HIV-Ab, Treponema pallidum antibody, or HCV-Ab.
✕. History of blood donation, significant blood loss (total volume ≥400 mL), or blood transfusion within 3 months prior to screening.
✕. History of alcohol abuse within 1 year prior to screening; or positive alcohol breath test.