Pharmacokinetic (PK) Study of GSK933776 in Healthy Volunteers
Status:
Completed
Trial end date:
2014-07-15
Target enrollment:
Participant gender:
Summary
This study is intended to enable a possible transition to intramuscular (IM) or subcutaneous
(SQ) administration for subsequent studies with GSK933776 by characterizing the safety,
tolerability, PK and pharmacodynamic profiles, and immunogenicity of GSK933776 following IM
and SQ administration in healthy volunteers. Such alternate routes of administration may
provide more options in the selection of an efficacious dose for subsequent development in
patients with geographic atrophy. There will be four treatment arms in the study and
participants will be assigned to 1 of 4 possible treatment arms in a 1:1:1:1 ratio. The
planned number of evaluable participants for this study is 24 with 6 participants completing
all critical assessments in each of the four treatment arms. The total duration of
participation from screening to follow-up for Treatment Arms A, B and D (single dose of
GSK933776), will be approximately 113 days and total duration for Treatment Arm C (repeat
dose of GSK933776) will be approximately 134 days.