definiens: means a clinical study of a drug candidate in hum an patients with the primary objective of characterizing its activity in a specific diseas e state as well as generating more detailed safety, tolerability, and pharmacokinetics information as d escribed in 21 C.F.R. § 312.21(b ), or a comparable clinical study prescribed by the relevant Regulator y Authority in a country other than the United Stat es including a human clinical study that is also desig ned to satisfy the requirements of 21 C.F.R. § 312.2 1(a ) or corresponding foreign regulations and is subsequ ently optimized or expanded to satisfy the requirem ents of 21 C.F.R. § 312.21(b ) ( or corresponding foreign r egulations ) or otherwise to enable a Phase 3 Clinic al Study ( e.g., a phase 1/2 trial ) . The relevant drug candidate may be administered t o patients as a single agent or in combination with other investigational or mar keted agents