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Not yet recruitingNCT07489599Updated Mar 24, 2026

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

A Phase 1 interventional study of QLH2405 and QLH2405 in Alzheimer's Disease(AD) and Mild Cognitive Impairment (MCI), sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease(AD)
  • Mild Cognitive Impairment (MCI)
03

In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's planned enrollment of 68 is close to the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Part A Cohort 1: Dose level 1 of QLH2405

    Participants will receive a single dose of QLH2405 at dose level 1.

    Drug: QLH2405

  • Experimental
    Part A Cohort 2: Dose level 2 of QLH2405

    Participants will receive a single dose of QLH2405 at dose level 2.

    Drug: QLH2405

  • Placebo comparator
    Part A Cohort 2: Placebo

    Participants will receive a single dose of matching placebo to level 2.

    Drug: Placebo

  • Experimental
    Part A Cohort 3: Dose level 3 of QLH2405

    Participants will receive a single dose of QLH2405 at dose level 3.

    Drug: QLH2405

  • Placebo comparator
    Part A Cohort 3: Placebo

    Participants will receive a single dose of matching placebo to level 3.

    Drug: Placebo

  • Experimental
    Part A Cohort 4: Dose level 4 of QLH2405

    Participants will receive a single dose of QLH2405 at dose level 4.

    Drug: QLH2405

  • Placebo comparator
    Part A Cohort 4: Placebo

    Participants will receive a single dose of matching placebo to level 4.

    Drug: Placebo

  • Experimental
    Part A Cohort 5: Dose level 5 of QLH2405

    Participants will receive a single dose of QLH2405 at dose level 5.

    Drug: QLH2405

  • Placebo comparator
    Part A Cohort 5: Placebo

    Participants will receive a single dose of matching placebo to level 5.

    Drug: Placebo

  • Experimental
    Part A Cohort 6: Dose level 6 of QLH2405

    Participants will receive a single dose of QLH2405 at dose level 6.

    Drug: QLH2405

  • Placebo comparator
    Part A Cohort 6: Placebo

    Participants will receive a single dose of matching placebo to level 6.

    Drug: Placebo

  • Experimental
    Part B Cohort 1: Dose level 3 of QLH2405

    Participants will receive a single dose of QLH2405 at dose level 3.

    Drug: QLH2405

  • Placebo comparator
    Part B Cohort 1: Placebo

    Participants will receive a single dose of matching placebo to level 3.

    Drug: Placebo

  • Experimental
    Part B Cohort 2: Dose level 4 of QLH2405

    Participants will receive a single dose of QLH2405 at dose level 4.

    Drug: QLH2405

  • Placebo comparator
    Part B Cohort 2: Placebo

    Participants will receive a single dose of matching placebo to level 4.

    Drug: Placebo

  • Experimental
    Part B Cohort 3: Dose level 5 of QLH2405

    Participants will receive a single dose of QLH2405 at dose level 5.

    Drug: QLH2405

  • Placebo comparator
    Part B Cohort 3: Placebo

    Participants will receive a single dose of matching placebo to level 5.

    Drug: Placebo

Interventions

  • DrugQLH2405

    QLH2405 will be administered as specified in each treatment arm.

  • DrugQLH2405

    QLH2405 will be administered as specified in each treatment arm.

  • DrugPlacebo

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

  • DrugQLH2405

    QLH2405 will be administered as specified in each treatment arm.

  • DrugPlacebo

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

  • DrugQLH2405

    QLH2405 will be administered as specified in each treatment arm.

  • DrugPlacebo

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

  • DrugQLH2405

    QLH2405 will be administered as specified in each treatment arm.

  • DrugPlacebo

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

  • DrugQLH2405

    QLH2405 will be administered as specified in each treatment arm.

  • DrugPlacebo

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

  • DrugQLH2405

    QLH2405 will be administered as specified in each treatment arm.

  • DrugPlacebo

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

  • DrugQLH2405

    QLH2405 will be administered as specified in each treatment arm.

  • DrugPlacebo

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

  • DrugQLH2405

    QLH2405 will be administered as specified in each treatment arm.

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Adverse Events (AEs)

    Percentage of Participants with AEs

    Time frame: Up to approximately 28 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07489599
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Mar 24, 2026
Start date
Mar 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Mar 24, 2026

Study contacts

Fangyi Wang, Bachelor
Contact
fangyi.wang@qilu-pharma.com
+86-18266419923

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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