A Clinical Study of AK139 in Healthy Subjects

NCT ID: NCT06947109

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-06
• Study Completion Date: 2026-01-30

Brief Summary

This is a phase I clinical study on dose escalation evaluating the safety, tolerability, PK and PD of a single dose of AK139 administered subcutaneously in healthy subjects.

Detailed Description

This is a phase I, dose escalation clinical study aimed to evaluate the safety, tolerability, PK and PD of AK139 in healthy subjects. This study will be conducted in a dose escalation design, sequentially increasing the dosage of the drug from low to high to complete a single subcutaneous dose escalation.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AK139 regimen

Group Type: ACTIVE_COMPARATOR

AK111

Intervention Type: DRUG

The study will use dose escalation scheme. Before proceeding to randomize the next group of subjects, the safety data from all subjects in the previous dose group must be reviewed and confirmed.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Monitor for a minimum of 24 hours to assess whether the safety and tolerability are acceptable according to the investigator.

Interventions

Placebo

Monitor for a minimum of 24 hours to assess whether the safety and tolerability are acceptable according to the investigator.

Intervention Type: DRUG

AK111

The study will use dose escalation scheme. Before proceeding to randomize the next group of subjects, the safety data from all subjects in the previous dose group must be reviewed and confirmed.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects voluntarily agree to participate and sign an informed consent form (ICF) before any study procedures begin.
• Male and female healthy subjects aged 18 to 55 at the time of signing the ICF.
• Male weight ≥ 50.0kg, female weight ≥ 45.0kg; Body Mass Index (BMI)=Weight (kg)/Height² (m²), within the range of 19.0~26.0 kg/m².
• Female subjects with fertility tested negative for pregnancy during the screening period.
• The subjects are able to communicate well with the investigator and understand and comply with the requirements of this study.

Exclusion Criteria

• Allergies to AK139 components and any monoclonal antibodies.
• Positive results of confirmatory serology test for hepatitis B, hepatitis C,HIV or syphilis at screening.
• have participated in any drug clinical study within 3 months prior to randomization, or are still within 5 half-lives after the last administration of other investigational drugs (whichever is longer)
• Previously or currently suffering from any diseases of the circulatory, endocrine, neurological, digestive, respiratory, urogenital, blood, immune, psychiatric, or metabolic systems that may interfere with the test results.
• History of parasitic infection.
• Drug abusers or individuals with positive urine drug results during screening.
• Have donated blood or experienced significant blood loss, received blood transfusions, or used blood products 3 months before screening.
• Investigator assessed that it is not suitable to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Guoqin Wang

Role: CONTACT

global.trials@akesobio.com

86 (0760) 8987 3999

Other Identifiers

AK139-101

Identifier Type: -

Identifier Source: org_study_id