Healthy Subjects
Conditions
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.
Interventions
DRUGPlacebo
Monitor for a minimum of 24 hours to assess whether the safety and tolerability are acceptable according to the investigator.
DRUGAK111
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.
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak concentration (Cmax) | Week 0 to week 12 | Measure and assess the Cmax of AK139. |
| Time to peak (Tmax) | Week 0 to week 12 | Measure and assess the Tmax of AK139 |
| Area under the curve (AUC) | Week 0 to week 12 | Measure and assess the AUC of AK139 |
| Half-life (t1/2) | Week 0 to week 12 | Measure and assess the t1/2 of AK139. |
| Anti-drug antibody (ADA) | Week 0/2/4/8/12 | Measure and assess the ADA of AK139. |
Countries
China
Contacts
Primary ContactGuoqin Wang
Outcome results
None listed