A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283

Официальное название

Open-Label, Randomized, Single Dose, Parallel Group, Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of Two Formulations of GSK5784283 Administered by Subcutaneous Injection

Обзор

The purpose of this study is to compare how two different formulations of the study medicine (GSK5784283) move through the body over time (pharmacokinetic \[PK\] study) in healthy adults. The aim of the study is to see how the body processes GSK5784283 and determine if the study medicine is safe, how well it is tolerated by the body and if the study medicines being tested work in the body in the same way.

Вмешательства

• Препарат GSK5784283
  GSK5784283 will be administered.

Первичные конечные точки

• Maximum Observed Concentration (Cmax) of GSK5784283 Serum Samples [Срок оценки: Pre-dose and up to 253 days post dose]
• Area Under the Curve from Zero up to 253 Days [AUC(0-253 d)] of GSK5784283 Serum Samples [Срок оценки: Pre-dose and up to 253 days post dose]

Вторичные конечные точки (3)

• Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs), Serious AEs and Adverse Event of Special Interest (AESI) [Срок оценки: Up to 253 days]
• Number of Participants with Clinically Significant Change from Baseline in Laboratory Assessments, Vital Signs and Electrocardiogram (ECG) Values [Срок оценки: Baseline and up to 253 days]
• Proportion of Participants with Anti-drug Antibody (ADA) Incidence, ADA Titre Assessment and Neutralizing Antibody (NAb) Incidence Against GSK5784283 [Срок оценки: Up to 253 days]

Критерии участия

Критерии включения

• Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
• Body weight greater than or equal (>=) 50 kilogram (kg) (110 pounds \[lbs\]) and body mass index within the range 19 to 30 kilogram per meter square (kg/m\^2) (inclusive).
• A female participant is eligible to participate if she is a participant of non-childbearing potential (PONCBP) as specified in the protocol.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Критерии исключения

• Hypersensitivity- Participants with allergy/intolerance to any biologic therapy or any of the known excipients used in products administered subcutaneously
• History or presence of any clinically significant medical condition 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.
• Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs during screening period which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
• Live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the clinical study.
• Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to study intervention administration.
• Current smokers (tobacco and/or marijuana) or former smokers with a smoking history >10 pack-years and participants using vaping products, including electronic cigarettes.
• Regular alcohol consumption that exceeds the limits specified in the protocol
• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study.
• The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), machine-read or manually over-read >450 millisecond (msec).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• GSK Investigational Site — Austin

Идентификаторы

NCT: NCT07712393 · 307918

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗