Alzheimer's Disease(AD)Phase 1NCT07489599
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 study testing QLH2405 in people with Alzheimer's Disease(AD) and Mild Cognitive Impairment (MCI), run by Qilu Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
- What is being tested?
- QLH2405
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily participate and sign the informed consent.
- Male or female, aged 18 to 65 years (inclusive).
- Healthy status as confirmed by medical evaluation.
- Body mass index (BMI) of 19-28 kg/m² (inclusive).
- Agree to use effective contraception and have no plans for sperm/egg donation or pregnancy from ICF signing until 9 months post-dose.
- Voluntarily participate and sign the informed consent, able to communicate well with the investigator and complete the trial per protocol.
Show all 12Show fewer
- Male or female, aged 50 to 85 years (inclusive).
- 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.
- Has subjective cognitive and memory decline for ≥6 months.
- Confirmation of Alzheimer's disease pathological changes by amyloid PET (Aβ-PET) scan.
- Has one (or more) reliable study partner (s)/adult caregiver(s) can accompany the participant to all visits.
- Agree to use effective contraception and have no plans for sperm/egg donation or pregnancy from ICF signing until 9 months post-dose.
Who cannot join
- History of significant diseases, or any existing disease may affect the study or pose an unacceptable risk to the participant.
- Positive for HBsAg, HIV-Ab, Treponema pallidum antibody, or HCV-Ab.
- History of blood donation, significant blood loss (total volume ≥400 mL), or blood transfusion within 3 months prior to screening.
- History of alcohol abuse within 1 year prior to screening; or positive alcohol breath test.
- History of drug abuse and/or substance abuse; or positive drug screening.
- Participation in any drug or medical device clinical trial within 3 months prior to screening.
Show all 16Show fewer
- Pregnant or lactating women, or women of childbearing potential with a positiveβ-hCG test.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.
- Cognitive impairment or dementia caused by any disease other than AD.
- History of stroke within 6 months prior to screening, or imaging evidence of clinically significant central nervous system diseases.
- History of epileptic seizures or epileptiform abnormalities on EEG within 6 months prior to screening.
- Unstable or severe diseases within 6 months prior to screening that, in the investigator's judgment, make the participant unsuitable for study participation.
- eGFR <60 mL/min/1.73 m².
- AST or ALT >3 × upper limit of normal (ULN), or total bilirubin >2 × ULN.
- Current use or anticipated need during the study period for any medication prohibited by the study protocol.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- QLH2405, Placebo
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLH2405Drug
QLH2405 will be administered as specified in each treatment arm.
QLH2405Drug
QLH2405 will be administered as specified in each treatment arm.
PlaceboDrug
QLH2405-matching placebo will be administered as specified in each treatment arm.
QLH2405Drug
QLH2405 will be administered as specified in each treatment arm.
PlaceboDrug
QLH2405-matching placebo will be administered as specified in each treatment arm.
QLH2405Drug
QLH2405 will be administered as specified in each treatment arm.
PlaceboDrug
QLH2405-matching placebo will be administered as specified in each treatment arm.
QLH2405Drug
QLH2405 will be administered as specified in each treatment arm.
PlaceboDrug
QLH2405-matching placebo will be administered as specified in each treatment arm.
QLH2405Drug
QLH2405 will be administered as specified in each treatment arm.
PlaceboDrug
QLH2405-matching placebo will be administered as specified in each treatment arm.
QLH2405Drug
QLH2405 will be administered as specified in each treatment arm.
PlaceboDrug
QLH2405-matching placebo will be administered as specified in each treatment arm.
QLH2405Drug
QLH2405 will be administered as specified in each treatment arm.
PlaceboDrug
QLH2405-matching placebo will be administered as specified in each treatment arm.
QLH2405Drug
QLH2405 will be administered as specified in each treatment arm.
PlaceboDrug
QLH2405-matching placebo will be administered as specified in each treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Part A Cohort 1: Dose level 1 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 1. Receives: Drug: QLH2405 |
| Part A Cohort 2: Dose level 2 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 2. Receives: Drug: QLH2405 |
| Part A Cohort 2: Placebo | Placebo comparator | Participants will receive a single dose of matching placebo to level 2. Receives: Drug: Placebo |
| Part A Cohort 3: Dose level 3 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 3. Receives: Drug: QLH2405 |
| Part A Cohort 3: Placebo | Placebo comparator | Participants will receive a single dose of matching placebo to level 3. Receives: Drug: Placebo |
| Part A Cohort 4: Dose level 4 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 4. Receives: Drug: QLH2405 |
| Part A Cohort 4: Placebo | Placebo comparator | Participants will receive a single dose of matching placebo to level 4. Receives: Drug: Placebo |
| Part A Cohort 5: Dose level 5 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 5. Receives: Drug: QLH2405 |
| Part A Cohort 5: Placebo | Placebo comparator | Participants will receive a single dose of matching placebo to level 5. Receives: Drug: Placebo |
| Part A Cohort 6: Dose level 6 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 6. Receives: Drug: QLH2405 |
| Part A Cohort 6: Placebo | Placebo comparator | Participants will receive a single dose of matching placebo to level 6. Receives: Drug: Placebo |
| Part B Cohort 1: Dose level 3 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 3. Receives: Drug: QLH2405 |
| Part B Cohort 1: Placebo | Placebo comparator | Participants will receive a single dose of matching placebo to level 3. Receives: Drug: Placebo |
| Part B Cohort 2: Dose level 4 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 4. Receives: Drug: QLH2405 |
| Part B Cohort 2: Placebo | Placebo comparator | Participants will receive a single dose of matching placebo to level 4. Receives: Drug: Placebo |
| Part B Cohort 3: Dose level 5 of QLH2405 | Experimental | Participants will receive a single dose of QLH2405 at dose level 5. Receives: Drug: QLH2405 |
| Part B Cohort 3: Placebo | Placebo comparator | Participants will receive a single dose of matching placebo to level 5. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Percentage of Participants with AEs
Measured: Up to approximately 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease(AD)Studies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489599
- Sponsor's protocol ID
- QLH2405-101
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07489599
- Acronym / sponsor ID
- QLH2405-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Part A Cohort 1: Dose level 1 of QLH2405 | Experimental | Drug: QLH2405Participants will receive a single dose of QLH2405 at dose level 1. |
| Part A Cohort 2: Dose level 2 of QLH2405 | Experimental | Drug: QLH2405Participants will receive a single dose of QLH2405 at dose level 2. |
| Part A Cohort 2: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of matching placebo to level 2. |
| Part A Cohort 3: Dose level 3 of QLH2405 | Experimental | Drug: QLH2405Participants will receive a single dose of QLH2405 at dose level 3. |
| Part A Cohort 3: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of matching placebo to level 3. |
| Part A Cohort 4: Dose level 4 of QLH2405 | Experimental | Drug: QLH2405Participants will receive a single dose of QLH2405 at dose level 4. |
| Part A Cohort 4: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of matching placebo to level 4. |
| Part A Cohort 5: Dose level 5 of QLH2405 | Experimental | Drug: QLH2405Participants will receive a single dose of QLH2405 at dose level 5. |
| Part A Cohort 5: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of matching placebo to level 5. |
| Part A Cohort 6: Dose level 6 of QLH2405 | Experimental | Drug: QLH2405Participants will receive a single dose of QLH2405 at dose level 6. |
| Part A Cohort 6: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of matching placebo to level 6. |
| Part B Cohort 1: Dose level 3 of QLH2405 | Experimental | Drug: QLH2405Participants will receive a single dose of QLH2405 at dose level 3. |
| Part B Cohort 1: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of matching placebo to level 3. |
| Part B Cohort 2: Dose level 4 of QLH2405 | Experimental | Drug: QLH2405Participants will receive a single dose of QLH2405 at dose level 4. |
| Part B Cohort 2: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of matching placebo to level 4. |
| Part B Cohort 3: Dose level 5 of QLH2405 | Experimental | Drug: QLH2405Participants will receive a single dose of QLH2405 at dose level 5. |
| Part B Cohort 3: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of matching placebo to level 5. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily participate and sign the informed consent.
- Male or female, aged 18 to 65 years (inclusive).
- Healthy status as confirmed by medical evaluation.
- Body mass index (BMI) of 19-28 kg/m² (inclusive).
- Agree to use effective contraception and have no plans for sperm/egg donation or pregnancy from ICF signing until 9 months post-dose.
Key exclusion criteria (16 listed)
- History of significant diseases, or any existing disease may affect the study or pose an unacceptable risk to the participant.
- Positive for HBsAg, HIV-Ab, Treponema pallidum antibody, or HCV-Ab.
- History of blood donation, significant blood loss (total volume ≥400 mL), or blood transfusion within 3 months prior to screening.
- History of alcohol abuse within 1 year prior to screening; or positive alcohol breath test.
- History of drug abuse and/or substance abuse; or positive drug screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLH2405QLH2405 will be administered as specified in each treatment arm. | Drug | Part A Cohort 1: Dose level 1 of QLH2405 |
| QLH2405QLH2405 will be administered as specified in each treatment arm. | Drug | Part A Cohort 2: Dose level 2 of QLH2405 |
| PlaceboQLH2405-matching placebo will be administered as specified in each treatment arm. | Drug | Part A Cohort 2: Placebo |
| QLH2405QLH2405 will be administered as specified in each treatment arm. | Drug | Part A Cohort 3: Dose level 3 of QLH2405 |
| PlaceboQLH2405-matching placebo will be administered as specified in each treatment arm. | Drug | Part A Cohort 3: Placebo |
| QLH2405QLH2405 will be administered as specified in each treatment arm. | Drug | Part A Cohort 4: Dose level 4 of QLH2405 |
| PlaceboQLH2405-matching placebo will be administered as specified in each treatment arm. | Drug | Part A Cohort 4: Placebo |
| QLH2405QLH2405 will be administered as specified in each treatment arm. | Drug | Part A Cohort 5: Dose level 5 of QLH2405 |
| PlaceboQLH2405-matching placebo will be administered as specified in each treatment arm. | Drug | Part A Cohort 5: Placebo |
| QLH2405QLH2405 will be administered as specified in each treatment arm. | Drug | Part A Cohort 6: Dose level 6 of QLH2405 |
| PlaceboQLH2405-matching placebo will be administered as specified in each treatment arm. | Drug | Part A Cohort 6: Placebo |
| QLH2405QLH2405 will be administered as specified in each treatment arm. | Drug | Part B Cohort 1: Dose level 3 of QLH2405 |
| PlaceboQLH2405-matching placebo will be administered as specified in each treatment arm. | Drug | Part B Cohort 1: Placebo |
| QLH2405QLH2405 will be administered as specified in each treatment arm. | Drug | Part B Cohort 2: Dose level 4 of QLH2405 |
| PlaceboQLH2405-matching placebo will be administered as specified in each treatment arm. | Drug | Part B Cohort 2: Placebo |
| QLH2405QLH2405 will be administered as specified in each treatment arm. | Drug | Part B Cohort 3: Dose level 5 of QLH2405 |
| PlaceboQLH2405-matching placebo will be administered as specified in each treatment arm. | Drug | Part B Cohort 3: Placebo |
Primary outcome
Adverse Events (AEs)
Time frame: Up to approximately 28 weeks
Percentage of Participants with AEs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
Related trials for Alzheimer's Disease(AD)
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLH2405 in people with Alzheimer's Disease(AD) and Mild Cognitive Impairment (MCI), run by Qilu Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fangyi Wang, Bachelor (+86-18266419923, fangyi.wang@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: Up to approximately 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.