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
17
Treatment groupsSee each treatment group below.