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

NCT07301502 | Not Yet Recruiting Phase 1

• 1 other identifier: AK152-101
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer' s Disease

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AE)

  The incidence of AEs.

  Up to approximately 8 weeks after the last dose

Secondary Outcomes (5)

• Peak concentration (Cmax)

  Up to approximately 8 weeks after the last dose

• Time to peak (Tmax)

  Up to approximately 8 weeks after the last dose

• Area under the curve (AUC)

  Up to approximately 8 weeks after the last dose

• Half-life (t1/2)

  Up to approximately 8 weeks after the last dose

• Immunogenicity characteristics of AK152

  Up to approximately 8 weeks after the last dose

Study Arms (2)

AK152 regimen

ACTIVE COMPARATOR

Drug: AK152

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AK152 DRUG

Subjects receiving single or multiple doses of AK152 injection.

AK152 regimen

Placebo DRUG

Subjects receiving single or multiple doses of placebo injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female subjects aged 18 to 40 years (inclusive) at the time of signing the informed consent form (ICF).
• Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; body mass index (BMI) = weight (kg) / height² (m²) within the range of 19.0-26.0 kg/m² (inclusive).
• Subjects agree to take protocol-specified contraception measures and refrain from donating sperm or oocytes from signing the ICF through the treatment period and for at least 90 days after the last administration of study drug; women of childbearing potential must be non-pregnant and non-lactating.
• Subjects are able to understand and voluntarily sign a written ICF before any study-specific procedures are performed, and are able to comply with the study procedures and follow-up requirements.

You may not qualify if:

• Known allergy to components of AK152 injection or any monoclonal antibody, or high risk of allergy.
• History or presence of any systemic disease that may interfere with study results.
• Clinically significant abnormalities in vital signs at screening or prior to randomization.
• Clinically significant laboratory abnormalities at screening or prior to randomization per investigator judgment.
• Use of any medication (including prescription, OTC, herbal medicines, dietary supplements) within 4 weeks before randomization or within 5 half-lives of the medication (whichever is longer), or planned use during the study.
• History of frequent alcohol consumption within 24 weeks or inability to abstain during inpatient stay.
• Drug abuse or positive urine drug screen at screening.
• Smokers consuming \>5 cigarettes/day within 12 weeks prior to screening or unable to abstain during the inpatient period.
• Excessive intake of tea, coffee, or other caffeine-containing beverages.
• Able to understand and voluntarily sign a written ICF before any study-specific procedures are performed, and able to comply with study procedures and follow-up requirements.
• Aged 50 to 85 years (inclusive) at the time of signing the ICF.
• BMI within 17.0-35.0 kg/m² (inclusive).
• Subjects agree to take protocol-specified contraception measures and refrain from donating sperm or oocytes from signing the ICF through the treatment period and for at least 90 days after the last dose; women must be non-pregnant and non-lactating.
• The subject must have an identified trial partner who must sign a separate ICF.
• Meets the 2011 NIA-AA core clinical criteria for MCI due to AD or mild AD dementia.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

The Frist Affiliated Hospital of USTC

Hefei, Anhui, China

Location

Central Study Contacts

Guoqin Wang

CONTACT

+86 (0760) 8987 3998; global.trials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)