A Clinical Study of AK139 in Healthy Subjects

Phase 1

Not yet recruiting

• Conditions: Healthy Subjects
• Interventions: Drug: AK111; Drug: Placebo

• Registration Number: NCT06947109
• Lead Sponsor: Akeso

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-21
• Study First Submitted QC: 2025-04-21
• Last Update Submitted: 2025-04-21
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27
• Study Start: 2025-05-06
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK139 regimen	AK111	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Adverse Events (AE)	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.

Secondary Outcome Measures

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