Study design and treatments
ICH
This Phase 1, single‐center, randomized, placebo‐controlled, double‐blind, single ascending dose study in healthy participants was conducted in the United States from 21 July 2020 to 21 December 2020. Following a screening period (of up to 28 days), participants who met the eligibility criteria were assigned to one of four cohorts and were randomly allocated within each cohort to receive a single dose of either GSK3772847 or placebo SC (Figure Study schema. SC, subcutaneousOn Day 1, participants were assigned a unique randomization number, encoding the participant's assignment to one of the four study arms according to the schedule generated prior to the study. In cohorts 1 and 2, 18 participants were randomly allocated to receive GSK3772847 70 mg (cohort 1) or GSK3772847 140 mg (cohort 2) SC, and six participants to receive placebo SC in each cohort. Participants in cohorts 1 and 2 were also randomized to one of three injection sites (upper arm, abdomen, or thigh). In cohort 3, six Japanese participants were randomly allocated to receive GSK3772847 140 mg SC, and two to receive placebo SC in the upper arm injection site. Finally, in cohort 4, six Chinese participants were randomized to receive GSK3772847 140 mg SC, and two to receive placebo SC in the upper arm injection site. Participants were admitted to the unit the day prior to dosing (Day 0) and were discharged after completion of assessments on Day 6. Participants attended follow‐up visits on Days 9, 15, 29, 43, 57, 71, and 85.The study protocol was reviewed and approved by an institutional review board in accordance with the International Conference on Harmonisation (ICH), Good Clinical Practice (GCP) and relevant country‐specific requirements, all applicable patient privacy requirements, and the guiding principles of the current version of the Declaration of Helsinki. Investigators were trained to conduct the study in accordance with GCP and the study protocol and all patients provided written informed consent prior to study participation. All study staff involved in clinical assessments, including the investigator, sub‐investigators and other site staff, and the participants were blinded to the individual treatments allocated.