A Study of QLH2405 in Healthy Participants and Participants With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single, Subcutaneous, Ascending Doses of QLH2405 Injection in Healthy Participants and Participants With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07489599

Enrollment

Registered

2026-03-24

Start date

2026-03-01

Completion date

2027-03-01

Last updated

2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)

Brief 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.

Interventions

DRUGQLH2405

QLH2405 will be administered as specified in each treatment arm.

DRUGPlacebo

QLH2405-matching placebo will be administered as specified in each treatment arm.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

for Part A: 1. Voluntarily participate and sign the informed consent. 2. Male or female, aged 18 to 65 years (inclusive). 3. Healthy status as confirmed by medical evaluation. 4. Body mass index (BMI) of 19-28 kg/m² (inclusive). 5. Agree to use effective contraception and have no plans for sperm/egg donation or pregnancy from ICF signing until 9 months post-dose. Inclusion Criteria for Part B: 1. Voluntarily participate and sign the informed consent, able to communicate well with the investigator and complete the trial per protocol. 2. Male or female, aged 50 to 85 years (inclusive). 3. 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. 4. Has subjective cognitive and memory decline for ≥6 months. 5. Confirmation of Alzheimer's disease pathological changes by amyloid PET (Aβ-PET) scan. 6. Has one (or more) reliable study partner (s)/adult caregiver(s) can accompany the participant to all visits. 7. Agree to use effective contraception and have no plans for sperm/egg donation or pregnancy from ICF signing until 9 months post-dose.

Exclusion criteria

for Part A: 1. History of significant diseases, or any existing disease may affect the study or pose an unacceptable risk to the participant. 2. Positive for HBsAg, HIV-Ab, Treponema pallidum antibody, or HCV-Ab. 3. History of blood donation, significant blood loss (total volume ≥400 mL), or blood transfusion within 3 months prior to screening. 4. History of alcohol abuse within 1 year prior to screening; or positive alcohol breath test. 5. History of drug abuse and/or substance abuse; or positive drug screening. 6. Participation in any drug or medical device clinical trial within 3 months prior to screening. 7. Pregnant or lactating women, or women of childbearing potential with a positiveβ-hCG test. 8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events (AEs)	Up to approximately 28 weeks	Percentage of Participants with AEs

Contacts

CONTACTFangyi Wang, Bachelor

fangyi.wang@qilu-pharma.com+86-18266419923

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026