drugset / Trial / NCT05590338

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1070806 After a Single Intravenous Dose in Healthy Male and Female Caucasian, Chinese and Japanese Participants Aged 18 to 65 Years of Age Inclusive

NCT05590338

Phase 1 Completed 38 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is divided into two parts: Part A of the study is double blinded, randomized, placebo-controlled and aims to assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamic (PD) effect of a single intravenous (IV) infusion dose of GSK1070806 when administered to healthy participants of Japanese, Chinese and European/Caucasian ancestry. Part B of the study is an open label single cohort arm to assess the safety, tolerability, PK and PD effect of a single IV bolus low dose of GSK1070806 in healthy participants of European/Caucasian ancestry.

Timeline

Start
2022-11-04
Primary completion
2023-07-12
Completion
2023-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK1070806 Monoclonal antibody Intravenous

Indications