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

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

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

Treatments tested in this trial

  • QLH2405
  • QLH2405
  • Placebo
  • QLH2405
  • Placebo
  • QLH2405
  • Placebo
  • QLH2405
  • Placebo
  • QLH2405
  • Placebo
  • QLH2405
  • Placebo
  • QLH2405
  • Placebo
  • QLH2405
  • Placebo

Treatment groups

68 Participants
are divided into 17 treatment groups

17

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators