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

March 18, 2026 updated by: Qilu Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A Cohort 1: Dose level 1 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 1.
Drug: QLH2405
QLH2405 will be administered as specified in each treatment arm.
Experimental: Part A Cohort 2: Dose level 2 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 2.
Drug: QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo Comparator: Part A Cohort 2: Placebo
Participants will receive a single dose of matching placebo to level 2.
Drug: Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
Experimental: Part A Cohort 3: Dose level 3 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 3.
Drug: QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo Comparator: Part A Cohort 3: Placebo
Participants will receive a single dose of matching placebo to level 3.
Drug: Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
Experimental: Part A Cohort 4: Dose level 4 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 4.
Drug: QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo Comparator: Part A Cohort 4: Placebo
Participants will receive a single dose of matching placebo to level 4.
Drug: Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
Experimental: Part A Cohort 5: Dose level 5 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 5.
Drug: QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo Comparator: Part A Cohort 5: Placebo
Participants will receive a single dose of matching placebo to level 5.
Drug: Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
Experimental: Part A Cohort 6: Dose level 6 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 6.
Drug: QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo Comparator: Part A Cohort 6: Placebo
Participants will receive a single dose of matching placebo to level 6.
Drug: Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
Experimental: Part B Cohort 1: Dose level 3 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 3.
Drug: QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo Comparator: Part B Cohort 1: Placebo
Participants will receive a single dose of matching placebo to level 3.
Drug: Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
Experimental: Part B Cohort 2: Dose level 4 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 4.
Drug: QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo Comparator: Part B Cohort 2: Placebo
Participants will receive a single dose of matching placebo to level 4.
Drug: Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.
Experimental: Part B Cohort 3: Dose level 5 of QLH2405
Participants will receive a single dose of QLH2405 at dose level 5.
Drug: QLH2405
QLH2405 will be administered as specified in each treatment arm.
Placebo Comparator: Part B Cohort 3: Placebo
Participants will receive a single dose of matching placebo to level 5.
Drug: Placebo
QLH2405-matching placebo will be administered as specified in each treatment arm.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QLH2405-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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