Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-01-16 @ 4:00 PM
Study NCT ID:
NCT07301502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of AK152 in Healthy Volunteers and Patients With Alzheimer' s Disease
Sponsor:
Akeso
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: