Health TrialsbyHealthPanel

A Study of GSK4771261 in Healthy Participants Aged 25 to 55 Years of Age Inclusive

ConditionKidney Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age25-55
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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/m²) (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

Trial design

Design model

Parallel

Treatments tested in this trial

  • GSK4771261

    Drug

    GSK4771261 will be administered.

  • Placebo

    Drug

    Placebo will be administered.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: GSK4771261Experimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Adverse Events (AEs), Injection Site Reactions, and Serious AEs (SAEs)

Time frame
Up to Week 13 (End of Study)
2

Number of Participants with Clinically Significant Changes from Baseline in Vital Signs

Time frame
Up to Week 13 (End of Study)
3

Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Values

Time frame
Up to Week 13 (End of Study)
4

Number of Participants with Clinically Significant Changes from Baseline in 12-Lead Electrocardiogram (ECG)

Time frame
Up to Week 13 (End of Study)

Secondary outcomes

1

Number of Participants with pre-existing Anti-Drug Antibodies (ADAs)

Time frame
Up to Week 13 (End of Study)
2

Number of Participants with treatment-emergent ADAs

Time frame
Up to Week 13 (End of Study)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
Apply now