A Clinical Study of AK139 in Healthy Subjects

Launched by AKESO · Apr 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called AK139 to see how safe it is and how the body processes it when given as a single dose to healthy adults. The study is in its early stages, known as Phase 1, and will involve participants aged 18 to 55. If you or someone you know is healthy, meets the weight and body measurement requirements, and is willing to take part, you might be eligible for this trial. Participants will need to sign a consent form and will be screened to ensure they don't have any conditions that might affect the study results.

During the trial, participants will receive a dose of AK139 through a shot under the skin. They will be monitored for any side effects and how the medication works in the body. Importantly, those with allergies to the medication, certain infections, or a history of specific health issues may not be able to participate. This study is a chance to help researchers learn more about AK139, which could contribute to future treatments.

Gender

ALL

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.