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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Cohort 1: Dose level 1 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 1. |
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| Part A Cohort 2: Dose level 2 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 2. |
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| Part A Cohort 2: Placebo | Placebo Comparator | Participants will receive a single dose of matching placebo to level 2. |
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| Part A Cohort 3: Dose level 3 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 3. |
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| Part A Cohort 3: Placebo | Placebo Comparator | Participants will receive a single dose of matching placebo to level 3. |
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| Part A Cohort 4: Dose level 4 of QLH2405 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLH2405 | Drug | QLH2405 will be administered as specified in each treatment arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Percentage of Participants with AEs | Up to approximately 28 weeks |
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Inclusion Criteria for Part A:
Inclusion Criteria for Part B:
Exclusion Criteria for Part A:
Exclusion Criteria for Part B:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fangyi Wang, Bachelor | Contact | +86-18266419923 | fangyi.wang@qilu-pharma.com |
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Participants will receive a single dose of QLH2405 at dose level 4.
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| Part A Cohort 4: Placebo | Placebo Comparator | Participants will receive a single dose of matching placebo to level 4. |
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| Part A Cohort 5: Dose level 5 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 5. |
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| Part A Cohort 5: Placebo | Placebo Comparator | Participants will receive a single dose of matching placebo to level 5. |
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| Part A Cohort 6: Dose level 6 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 6. |
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| Part A Cohort 6: Placebo | Placebo Comparator | Participants will receive a single dose of matching placebo to level 6. |
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| Part B Cohort 1: Dose level 3 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 3. |
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| Part B Cohort 1: Placebo | Placebo Comparator | Participants will receive a single dose of matching placebo to level 3. |
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| Part B Cohort 2: Dose level 4 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 4. |
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| Part B Cohort 2: Placebo | Placebo Comparator | Participants will receive a single dose of matching placebo to level 4. |
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| Part B Cohort 3: Dose level 5 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 5. |
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| Part B Cohort 3: Placebo | Placebo Comparator | Participants will receive a single dose of matching placebo to level 5. |
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| QLH2405 | Drug | QLH2405 will be administered as specified in each treatment arm. |
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| Placebo | Drug | QLH2405-matching placebo will be administered as specified in each treatment arm. |
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| QLH2405 | Drug | QLH2405 will be administered as specified in each treatment arm. |
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| Placebo | Drug | QLH2405-matching placebo will be administered as specified in each treatment arm. |
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| QLH2405 | Drug | QLH2405 will be administered as specified in each treatment arm. |
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| Placebo | Drug | QLH2405-matching placebo will be administered as specified in each treatment arm. |
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| QLH2405 | Drug | QLH2405 will be administered as specified in each treatment arm. |
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| Placebo | Drug | QLH2405-matching placebo will be administered as specified in each treatment arm. |
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| QLH2405 | Drug | QLH2405 will be administered as specified in each treatment arm. |
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| Placebo | Drug | QLH2405-matching placebo will be administered as specified in each treatment arm. |
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| QLH2405 | Drug | QLH2405 will be administered as specified in each treatment arm. |
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| Placebo | Drug | QLH2405-matching placebo will be administered as specified in each treatment arm. |
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| QLH2405 | Drug | QLH2405 will be administered as specified in each treatment arm. |
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| Placebo | Drug | QLH2405-matching placebo will be administered as specified in each treatment arm. |
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| QLH2405 | Drug | QLH2405 will be administered as specified in each treatment arm. |
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| Placebo | Drug | QLH2405-matching placebo will be administered as specified in each treatment arm. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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