Kidney Disease
Conditions
Keywords
GSK4771261, Healthy Volunteers, Pharmacokinetics, Pharmacodynamics, Immunogenicity, Chinese Ancestry, Japanese Ancestry, White/European Ancestry
Brief summary
This is a first time in Asia (FTIA) study of GSK4771261 in healthy participants of Chinese, Japanese, and White/European ancestry. The study will test whether GSK4771261 is safe, well-tolerated, how it is processed in the body, and whether it triggers an immune response.
Interventions
DRUGGSK4771261
GSK4771261 will be administered.
DRUGPlacebo
Placebo will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the normal reference range for the population being studied may be included only if the Investigator, in their clinical judgement, believes and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Body weight at least 50.0 kilograms (kg) for male participants or at least 45.0 kg for female participants at screening * Body Mass Index (BMI) within the range of 18.0 - 28.0 kilogram per square meters (kg/m\^2) (inclusive) at screening * A female participant is eligible to participate if she is not pregnant or breastfeeding, and is a Participant of non-childbearing potential (PONCBP) * Capable of giving signed informed consent * Participants of Chinese ancestry or Japanese ancestry or White/European ancestry are eligible based on meeting all the following criteria: * Participants of Chinese ancestry: Born in mainland China, Hong Kong, or Taiwan; descendant of 4 ethnic Chinese grandparents and 2 ethnic Chinese parents; and have lived outside mainland China, Hong Kong, or Taiwan for less than 10 years at the time of screening * Participants of Japanese ancestry: born in Japan; descendant of 4 ethnic Japanese grandparents and 2 ethnic Japanese parents; and have lived outside Japan for less than 10 years at the time of screening * Participants of White/European ancestry: Self-identified as being of White/European ancestry (i.e., from the original peoples of Europe) irrespective of place of birth and current place of residence; and descendant of 4 grandparents and 2 parents of White/European ancestry (i.e., from the original peoples of Europe) irrespective of place of birth or current place of residence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AEs), Injection Site Reactions, and Serious AEs (SAEs) | Up to Week 13 (End of Study) |
| Number of Participants with Clinically Significant Changes from Baseline in Vital Signs | Up to Week 13 (End of Study) |
| Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Values | Up to Week 13 (End of Study) |
| Number of Participants with Clinically Significant Changes from Baseline in 12-Lead Electrocardiogram (ECG) | Up to Week 13 (End of Study) |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-t]) | Up to Week 13 |
| Area under the serum concentration-time curve extrapolated to infinite time (AUC[0-inf]) | Up to Week 13 |
| Maximum observed serum concentration (Cmax) | Up to Week 13 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with pre-existing Anti-Drug Antibodies (ADAs) | Up to Week 13 (End of Study) |
| Number of Participants with treatment-emergent ADAs | Up to Week 13 (End of Study) |
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed