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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

ConditionsAlzheimer's Disease(AD)Mild Cognitive Impairment (MCI)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • QLH2405

    Drug

    QLH2405 will be administered as specified in each treatment arm.

  • QLH2405

    Drug

    QLH2405 will be administered as specified in each treatment arm.

  • Placebo

    Drug

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

  • QLH2405

    Drug

    QLH2405 will be administered as specified in each treatment arm.

  • Placebo

    Drug

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

  • QLH2405

    Drug

    QLH2405 will be administered as specified in each treatment arm.

  • Placebo

    Drug

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

  • QLH2405

    Drug

    QLH2405 will be administered as specified in each treatment arm.

  • Placebo

    Drug

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

  • QLH2405

    Drug

    QLH2405 will be administered as specified in each treatment arm.

  • Placebo

    Drug

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

  • QLH2405

    Drug

    QLH2405 will be administered as specified in each treatment arm.

  • Placebo

    Drug

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

  • QLH2405

    Drug

    QLH2405 will be administered as specified in each treatment arm.

  • Placebo

    Drug

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

  • QLH2405

    Drug

    QLH2405 will be administered as specified in each treatment arm.

  • Placebo

    Drug

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

Treatment groups

68 Participants
are divided into 17 treatment groups

17

Treatment groups

See each treatment group below.

Group A: Part A Cohort 1: Dose level 1 of QLH2405Experimental treatment 1 intervention
Group B: Part A Cohort 2: Dose level 2 of QLH2405Experimental treatment 1 intervention
Group C: Part A Cohort 2: PlaceboPlacebo comparator 1 intervention
Group D: Part A Cohort 3: Dose level 3 of QLH2405Experimental treatment 1 intervention
Group E: Part A Cohort 3: PlaceboPlacebo comparator 1 intervention
Group F: Part A Cohort 4: Dose level 4 of QLH2405Experimental treatment 1 intervention
Group G: Part A Cohort 4: PlaceboPlacebo comparator 1 intervention
Group H: Part A Cohort 5: Dose level 5 of QLH2405Experimental treatment 1 intervention
Group I: Part A Cohort 5: PlaceboPlacebo comparator 1 intervention
Group J: Part A Cohort 6: Dose level 6 of QLH2405Experimental treatment 1 intervention
Group K: Part A Cohort 6: PlaceboPlacebo comparator 1 intervention
Group L: Part B Cohort 1: Dose level 3 of QLH2405Experimental treatment 1 intervention
Group M: Part B Cohort 1: PlaceboPlacebo comparator 1 intervention
Group N: Part B Cohort 2: Dose level 4 of QLH2405Experimental treatment 1 intervention
Group O: Part B Cohort 2: PlaceboPlacebo comparator 1 intervention
Group P: Part B Cohort 3: Dose level 5 of QLH2405Experimental treatment 1 intervention
Group Q: Part B Cohort 3: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events (AEs)

Percentage of Participants with AEs

Time frame
Up to approximately 28 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: