Status:
NOT_YET_RECRUITING
A Clinical Study of AK139 in Healthy Subjects
Lead Sponsor:
Akeso
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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, sequenti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06947109
Start Date
May 6 2025
End Date
January 30 2026
Last Update
April 27 2025
Active Locations (1)
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1
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, China