UP-818-CC Injection in Healthy Chinese Subjects

Summary

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.

Timeline

Start

2022-02-14

Primary completion

2023-01-12

Completion

2023-02-20

Drugs

Indications

No indication recorded.