Clinical trial NCT06947109: A Clinical Study of AK139 in Healthy Subjects
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2025-04-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Adverse Events (AE)
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Peak concentration (Cmax)
timeFrame: Week 0 to week 12
measure: Time to peak (Tmax)
timeFrame: Week 0 to week 12
measure: Area under the curve (AUC)
timeFrame: Week 0 to week 12
measure: Half-life (t1/2)
timeFrame: Week 0 to week 12
measure: Anti-drug antibody (ADA)
timeFrame: Week 0/2/4/8/12
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Xiaoshan Hospital
state: Zhejiang
Study officials:
References: