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Clinical Trial NCT07489599 for Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study of QLH2405 in Healthy Participants and Participants With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease Phase 1 68

Not yet recruiting
Clinical Trial NCT07489599 is designed to study Treatment for Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI). This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on March 1, 2026 until the study accrues 68 participants. Led by Qilu Pharmaceutical Co., Ltd., this study is expected to complete by March 1, 2027. The latest data from ClinicalTrials.gov was last updated on March 24, 2026.
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.
Official Title

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

Conditions
Alzheimer's Disease(AD)Mild Cognitive Impairment (MCI)
Other Study IDs
  • QLH2405-101
NCT ID Number
Start Date (Actual)
2026-03
Last Update Posted
2026-03-24
Completion Date (Estimated)
2027-03
Enrollment (Estimated)
68
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPart A Cohort 1: Dose level 1 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 1.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
ExperimentalPart A Cohort 2: Dose level 2 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 2.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo ComparatorPart A Cohort 2: Placebo
Participants will receive a single dose of matching placebo to level 2.
Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
ExperimentalPart A Cohort 3: Dose level 3 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 3.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo ComparatorPart A Cohort 3: Placebo
Participants will receive a single dose of matching placebo to level 3.
Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
ExperimentalPart A Cohort 4: Dose level 4 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 4.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo ComparatorPart A Cohort 4: Placebo
Participants will receive a single dose of matching placebo to level 4.
Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
ExperimentalPart A Cohort 5: Dose level 5 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 5.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo ComparatorPart A Cohort 5: Placebo
Participants will receive a single dose of matching placebo to level 5.
Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
ExperimentalPart A Cohort 6: Dose level 6 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 6.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo ComparatorPart A Cohort 6: Placebo
Participants will receive a single dose of matching placebo to level 6.
Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
ExperimentalPart B Cohort 1: Dose level 3 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 3.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo ComparatorPart B Cohort 1: Placebo
Participants will receive a single dose of matching placebo to level 3.
Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
ExperimentalPart B Cohort 2: Dose level 4 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 4.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo ComparatorPart B Cohort 2: Placebo
Participants will receive a single dose of matching placebo to level 4.
Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
ExperimentalPart B Cohort 3: Dose level 5 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 5.
QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo ComparatorPart B Cohort 3: Placebo
Participants will receive a single dose of matching placebo to level 5.
Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Adverse Events (AEs)
Percentage of Participants with AEs
Up to approximately 28 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  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.

  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.

Exclusion Criteria for Part B:

  1. Cognitive impairment or dementia caused by any disease other than AD.
  2. History of stroke within 6 months prior to screening, or imaging evidence of clinically significant central nervous system diseases.
  3. History of epileptic seizures or epileptiform abnormalities on EEG within 6 months prior to screening.
  4. Unstable or severe diseases within 6 months prior to screening that, in the investigator's judgment, make the participant unsuitable for study participation.
  5. eGFR <60 mL/min/1.73 m².
  6. AST or ALT >3 × upper limit of normal (ULN), or total bilirubin >2 × ULN.
  7. Current use or anticipated need during the study period for any medication prohibited by the study protocol.
  8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.
Qilu Pharmaceutical Co., Ltd. logoQilu Pharmaceutical Co., Ltd.
Study Central Contact
Contact: Fangyi Wang, Bachelor, +86-18266419923, [email protected]
No location data.