Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy and Obese Subjects
Launched by ASCLETIS PHARMA (CHINA) CO., LIMITED · May 19, 2024
Trial Information
Current as of February 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called ASC47 to see how safe it is and how it works in the body. The trial will involve healthy adults aged 18 to 55 years who meet certain health criteria. Participants will be randomly assigned to receive either the medication or a placebo (a harmless sugar pill) during a single dose treatment. The goal is to gather information on how the medication is processed by the body and its effects, particularly related to a condition known as NASH, which affects the liver.
To be eligible for this trial, participants must be in good health and not have any serious medical conditions, especially related to the heart, liver, or other major systems. Women who are pregnant or breastfeeding, or those planning to become pregnant soon, cannot participate. During the study, participants will go through a screening period, receive the treatment, and then have a follow-up period to monitor their health. This trial is currently recruiting participants, and those interested should carefully consider the eligibility criteria before applying.
Gender
ALL
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.
About Ascletis Pharma (China) Co., Limited
Ascletis Pharma (China) Co., Limited is a biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapies for the treatment of viral infections, liver diseases, and cancer. Founded in 2013 and headquartered in Hangzhou, China, Ascletis leverages cutting-edge technology and a robust pipeline of drug candidates to address unmet medical needs globally. With a strong commitment to advancing healthcare, the company collaborates with leading research institutions and industry partners to bring high-quality, effective treatments to market, enhancing patient outcomes and improving quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Herston, Queensland, Australia
Herston, Queensland, Australia
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0