Chronic Weight Management
Conditions
Keywords
ASC47
Brief summary
This will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period. This study aims to evaluate the pharmacokinetics and target engagement of ASC47 in healthy and obese subjects.
Interventions
DRUGASC47
single subcutaneous injection of ASC47
DRUGMatching placebo
single subcutaneous injection of Placebo
Sponsors
Ascletis Pharma (China) Co., Limited
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key inclusion Criteria: * Subject have provided informed consent before initiation of any study-specific procedures * Healthy male subjects or female subjects, between 18 and 55 years of age (inclusive). * Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible. * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, eg. Key
Exclusion criteria
* Have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator. * Have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders. * Have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia. * Have a history of febrile illness within 14 days prior to screening. * Have a positive alcohol or drug screen at Screening or have a history of alcohol or drug abuse within the past 1 years. * Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. * Have used prescription drugs (other than hormone replacement therapy and medications for contraceptive purpose) within 14 days prior to the first dose of Investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to 57 days | Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days. |
| ECG QT Interval | up to 57 days | Evaluate the ECG QT Interval after single doses of ASC47. |
| Blood cell | up to 57 days | Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47. |
| Hematology | up to 57 days | Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CL/F of ASC47 | up to 57 days | Evaluate the Apparent Systemic Clearance after single doses of ASC47. |
| AUC of ASC47 | up to 57 days | Evaluate the Area under the plasma concentration versus time curve after single doses of ASC47. |
| Lipid parameters | up to 57 days | Evaluate the LDL-C, TG, TC, HDL-C after single doses of ASC47. |
| Vd/F of ASC47 | up to 57 days | Evaluate the Apparent Volume of Distribution after single doses of ASC47. |
| Cmax of ASC47 | up to 57 days | Evaluate the Peak Plasma Concentration after single doses of ASC47. |
| Cmin of ASC47 | up to 57 days | Evaluate the Minimum Plasma Concentration after single doses of ASC47. |
| T1/2 of ASC47 | up to 57 days | Evaluate the Terminal-Phase Half-Life after single doses of ASC47 |
Countries
Australia
Outcome results
None listed