A Clinical Study of AK139 in Healthy Subjects

Akeso

Status and phase

Not yet enrolling

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: AK111

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06947109

AK139-101

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.