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Recruiting Phase 1 NCT07335198

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 Parameters

Condition Non-alcoholic Fatty Liver Disease
Sponsor GlaxoSmithKline
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 55 Years
Start Date 2026-03-05
Completion 2026-08-17
Interventions
Efimosfermin alfaPlacebo

Brief Summary

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

Inclusion Criteria: Participants who are generally healthy as determined by medical evaluation * 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/m\^2) (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. * 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, (i.e., from the original peoples of Europe) irrespective of current place of residence; and. * Descendant of 2 parents and 4 gr

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