NCT07489599

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alzheimer's Disease(AD)
• Mild Cognitive Impairment (MCI)

Interventions

Type	Name	Description
DRUG	QLH2405	QLH2405 will be administered as specified in each treatment arm.
DRUG	QLH2405	QLH2405 will be administered as specified in each treatment arm.
DRUG	Placebo	QLH2405-matching placebo will be administered as specified in each treatment arm.
DRUG	QLH2405	QLH2405 will be administered as specified in each treatment arm.
DRUG	Placebo	QLH2405-matching placebo will be administered as specified in each treatment arm.
DRUG	QLH2405	QLH2405 will be administered as specified in each treatment arm.
DRUG	Placebo	QLH2405-matching placebo will be administered as specified in each treatment arm.
DRUG	QLH2405	QLH2405 will be administered as specified in each treatment arm.
DRUG	Placebo	QLH2405-matching placebo will be administered as specified in each treatment arm.
DRUG	QLH2405	QLH2405 will be administered as specified in each treatment arm.
DRUG	Placebo	QLH2405-matching placebo will be administered as specified in each treatment arm.
DRUG	QLH2405	QLH2405 will be administered as specified in each treatment arm.
DRUG	Placebo	QLH2405-matching placebo will be administered as specified in each treatment arm.
DRUG	QLH2405	QLH2405 will be administered as specified in each treatment arm.
DRUG	Placebo	QLH2405-matching placebo will be administered as specified in each treatment arm.
DRUG	QLH2405	QLH2405 will be administered as specified in each treatment arm.
DRUG	Placebo	QLH2405-matching placebo will be administered as specified in each treatment arm.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2026-03-24
• Last updated: 2026-03-24