This is a first time in Asia (FTIA) study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and immunogenicity of efimosfermin alfa to healthy participants of Chinese, Japanese, and White/European ancestry.
Body weight at least 50.0 Kilogram (kg) for male participants or at least 45.0 kg for female participants
Body mass index (BMI) within the range of 18.0 to 28.0 kilograms per square meter (kg/m²) (inclusive)
Male and female participants
Participants of Chinese ancestry are eligible if born in mainland China, Hong Kong, or Taiwan, and have lived outside China, Hong Kong, or Taiwan for less than 10 years at the time of screening.
History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
Current or chronic history of liver or biliary disease with the exception of Gilbert's syndrome or asymptomatic gallstones.
History of pancreatic injury, pancreatitis or other pancreatic disease; history of Type one Diabetes Mellitus (T1DM) or positive glutamic acid decarboxylase auto-antibodies, or major Type two Diabetes Mellitus (T2DM) complications including severe gastroparesis and autonomic neuropathy.
Abnormal blood pressure (defined as systolic Blood Pressure (BP) more than equal (>=)140 millimeters of mercury (mmHg) or diastolic BP >=90 mmHg) measured based on the average of triplicate BP readings).
Parallel
Efimosfermin alfa
DrugEfimosfermin alfa to be administered
Placebo
DrugPlacebo to be administered
6
Treatment groupsSee each treatment group below.
Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs)
Number of participants with clinically significant changes in hematology, chemistry and urinalysis parameters
Number of participants with clinically significant changes in 12 Lead electrocardiogram (ECG)
Number of participants with clinically significant changes in vital signs
Time to maximum observed serum drug concentration (Tmax) of efimosfermin alfa
Apparent terminal phase half-life (t1/2) of efimosfermin alfa
Area under the serum drug concentration versus time curve from time zero to 90 days [AUC(0-90days)] of efimosfermin alfa
Time of last quantifiable plasma drug concentration (Tlast) of efimosfermin alfa
Click on the lead sponsor to view all of their trials.
