The objectives of this study are to evaluate the safety, tolerability and pharmacokinetic characteristics in healthy Chinese volunteers after single and multiple dose of intravenous infusion of UP-818-CC.
This study is divided into two parts, single ascending dose part (SAD) and multiple ascending dose part (MAD), both conducted in healthy subjects, using a randomized, double-blind, placebo-controlled, dose-escalating design.
The SAD part is planned to be carried out in 6 dose groups. A total of about 43 healthy adult subjects are planned to be included. All subjects will receive a single dose on the first day (D1).
According to the obtained PK and safety information of the SAD, three appropriate dose groups are selected in MAD. A total of about 30 healthy adult subjects, both male and female, will be included. All subjects will receive multiple doses from D1 to D7, once daily.