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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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