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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Efimosfermin alfa
  • Placebo

Treatment groups

30 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators