A Study of QLH2405 in Healthy Participants and Participants With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
NCT07489599 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2026-03-24
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.
Conditions
- Alzheimer's Disease(AD)
- Mild Cognitive Impairment (MCI)
Interventions
- DRUG
-
QLH2405
QLH2405 will be administered as specified in each treatment arm.
- DRUG
-
QLH2405
QLH2405 will be administered as specified in each treatment arm.
- DRUG
-
QLH2405-matching placebo will be administered as specified in each treatment arm.
- DRUG
-
QLH2405
QLH2405 will be administered as specified in each treatment arm.
- DRUG
-
QLH2405-matching placebo will be administered as specified in each treatment arm.
- DRUG
-
QLH2405
QLH2405 will be administered as specified in each treatment arm.
- DRUG
-
QLH2405-matching placebo will be administered as specified in each treatment arm.
- DRUG
-
QLH2405
QLH2405 will be administered as specified in each treatment arm.
- DRUG
-
QLH2405-matching placebo will be administered as specified in each treatment arm.
- DRUG
-
QLH2405
QLH2405 will be administered as specified in each treatment arm.
- DRUG
-
QLH2405-matching placebo will be administered as specified in each treatment arm.
- DRUG
-
QLH2405
QLH2405 will be administered as specified in each treatment arm.
- DRUG
-
QLH2405-matching placebo will be administered as specified in each treatment arm.
- DRUG
-
QLH2405
QLH2405 will be administered as specified in each treatment arm.
- DRUG
-
QLH2405-matching placebo will be administered as specified in each treatment arm.
- DRUG
-
QLH2405
QLH2405 will be administered as specified in each treatment arm.
- DRUG
-
QLH2405-matching placebo will be administered as specified in each treatment arm.
Sponsors & Collaborators
-
Qilu Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2027-03-31
- Completion
- 2027-03-31
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