The first patient has been dosed in Lipocene's (NASDAQ:LPCN) Phase 2b clinical study for LPCN 1111, its novel testosterone replacement therapy product candidate.
The market did not seem pumped up by the news, as the shares shed 3.9% at US$12.42 in early trading.
The primary objectives of the study will be to determine the optimal dose of LPCN 1111, along with the safety and tolerability of LPCN 1111 and its metabolites following oral administration of single and multiple doses of LPCN 1111 in males suffering a diminished functional activity of the gonads.
"Progress with this product builds on our leadership position in oral testosterone replacement therapy," said Dr Mahesh Patel, president and chief executive officer of Lipocine.
LPCN 1111 is a follow-on product candidate to LPCN 1021, a twice-daily oral testosterone product candidate that is currently under regulatory review with a Food & Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of June 28, 2016.