Placebo: Monitor for a minimum of 24 hours to assess whether the safety and tolerability are acceptable according to the investigator.
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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 outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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