A Clinical Study of AK139 in Healthy Subjects

April 21, 2025 updated by: Akeso

A Phase I Clinical Study on Dose Escalation Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Dose of AK139 in Healthy Subjects.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Xiaoshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Monitor for a minimum of 24 hours to assess whether the safety and tolerability are acceptable according to the investigator.
Active Comparator: AK139 regimen
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AE)
Time Frame: Baseline to week 12
The incidence of AEs . An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Baseline to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak concentration (Cmax)
Time Frame: Week 0 to week 12
Measure and assess the Cmax of AK139.
Week 0 to week 12
Time to peak (Tmax)
Time Frame: Week 0 to week 12
Measure and assess the Tmax of AK139
Week 0 to week 12
Area under the curve (AUC)
Time Frame: Week 0 to week 12
Measure and assess the AUC of AK139
Week 0 to week 12
Half-life (t1/2)
Time Frame: Week 0 to week 12
Measure and assess the t1/2 of AK139.
Week 0 to week 12
Anti-drug antibody (ADA)
Time Frame: Week 0/2/4/8/12
Measure and assess the ADA of AK139.
Week 0/2/4/8/12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akeso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 6, 2025

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • AK139-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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