A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry

Korábbi kezelés

• Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever was longer; or longer if required by local regulations.
• Participants who have received native FGF21 or a FGF21 analog at any time in the past.
• Intended use of over the counter (OTC) or prescription medication (including herbal medications) within 7 days prior to dosing and for the duration of study participation.
• Live vaccine within 14 days prior to dosing and non-live vaccines for 7 days prior study dosing.
• Current enrolment or participation in another clinical trial within the last 30 days before signing consent of current study.
• Presence of hepatitis B surface antigen (HBsAg) or hepatitis C antibody at screening or within 3 months prior to the first dose of study intervention
• A positive pre-study drug/alcohol screen

Más betegség

• 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.
• History of metabolic bone disorders including osteoporosis, osteopenia, or osteomalacia.
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
• Known bleeding disorder.
• History of immunodeficiency diseases, including a positive test result for human immunodeficiency virus (HIV).
• Use of statins, other lipid lowering medications or hypertension medications unless on a stable dose for at least 3 months.

Laborértékek

• Alanine transaminase (ALT) more than (>)1.5 * upper limit of normal (ULN).
• Total bilirubin >1.5 * ULN
• Corrected QT Interval using Fridericia's Formula (QTcF) >=450 millisecond (msec)(male) or >=470 msec (female) at Screening Visit based on the average of triplicate ECGs.

Egyéb

• 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).

• Participants who are generally healthy as determined by medical evaluation
• Body weight at least 50.0 kilograms (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/m\^2) (inclusive)
• Male and female participants
• Participants of Chinese ancestry are eligible if born in mainland China, Hong Kong, or Taiwan, and descendant of 2 ethnic Chinese parents and 4 ethnic Chinese grandparents; and have lived outside China, Hong Kong, or Taiwan for less than 10 years at the time of screening.
• Participants of Japanese ancestry are eligible if born in Japan and descendant of 2 ethnic Japanese parents and 4 ethnic Japanese grandparents; and have lived outside Japan for less than 10 years at the time of screening.
• Participants of White/European ancestry are eligible if self-identified as being of White/European ancestry, (that is [i.e.], from the original peoples of Europe) irrespective of current place of residence; and descendant of 2 parents and 4 grandparents of White/European ancestry (i.e., from the original peoples of Europe) irrespective of place of birth or current place of residence.