Clinical trial NCT06427590: A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy and Obese Subjects
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Weight Management
Keywords: ASC47
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: up to 57 days
measure: ECG QT Interval
timeFrame: up to 57 days
measure: Blood cell
timeFrame: up to 57 days
measure: Hematology
timeFrame: up to 57 days
Secondary outcomes:
measure: AUC of ASC47
timeFrame: up to 57 days
measure: Cmax of ASC47
timeFrame: up to 57 days
measure: Cmin of ASC47
timeFrame: up to 57 days
measure: T1/2 of ASC47
timeFrame: up to 57 days
measure: CL/F of ASC47
timeFrame: up to 57 days
measure: Vd/F of ASC47
timeFrame: up to 57 days
measure: Lipid parameters
timeFrame: up to 57 days
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Ascletis
state: Queensland
Study officials:
References: