Ascletis
Herston, Queensland, 4006, Australia
NCT Number: NCT06427590
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Herston, Queensland, 4006, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key inclusion Criteria:
Key exclusion Criteria:
single subcutaneous injection of ASC47
single subcutaneous injection of Placebo
Time frame: 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.
Time frame: up to 57 days
Evaluate the ECG QT Interval after single doses of ASC47.
Time frame: 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.
Time frame: up to 57 days
Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.
Time frame: up to 57 days
Evaluate the Area under the plasma concentration versus time curve after single doses of ASC47.
Time frame: up to 57 days
Evaluate the Peak Plasma Concentration after single doses of ASC47.
Time frame: up to 57 days
Evaluate the Minimum Plasma Concentration after single doses of ASC47.
Time frame: up to 57 days
Evaluate the Terminal-Phase Half-Life after single doses of ASC47
Time frame: up to 57 days
Evaluate the Apparent Systemic Clearance after single doses of ASC47.
Time frame: up to 57 days
Evaluate the Apparent Volume of Distribution after single doses of ASC47.
Time frame: up to 57 days
Evaluate the LDL-C, TG, TC, HDL-C after single doses of ASC47.
Ascletis Pharma (China) Co., Limited
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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