NCT07301502

A Clinical Trial of AK152 in Healthy Volunteers and Patients With Alzheimer' s Disease

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients With Alzheimer' s Disease

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind phase I clinical trial to evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients with Alzheimer' s Disease.

Detailed description

This is a randomized, double-blind phase I clinical trial to evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients with Alzheimer' s Disease. Subjects will be randomized to receive AK152 regimen or placebo treatment.

Conditions

• Alzheimer' s Disease

Interventions

Type	Name	Description
DRUG	AK152	Subjects receiving single or multiple doses of AK152 injection.
DRUG	Placebo	Subjects receiving single or multiple doses of placebo injection.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-12-24
• Last updated: 2025-12-24

Locations

1 site across 1 country: China