The Safety and Tolerability of WS016 in Healthy Chinese Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

February 13, 2023

Primary Completion Date

June 15, 2023

Study Completion Date

June 15, 2023

Conditions
Hyperkalemia
Interventions
DRUG

WS016 Single Dose(6g)

WS016 6g, to be administered orally as a single dose.

DRUG

WS016 Single Dose(12g)

WS016 12g, to be administered orally as a single dose.

DRUG

WS016 Single Dose(24g)

WS016 24g, to be administered orally as a single dose.

DRUG

WS016 Single Dose(36g)

WS016 36g, to be administered orally as a single dose.

DRUG

WS016 Single Dose(48g)

WS016 48g, to be administered orally as a single dose.

DRUG

SAD matching placebo

Matching placebo, to be administered orally as a single dose.

DRUG

WS016 Multiple Dose(12g)

WS016 12g, to be administered orally once daily for a consecutive period of 7 days.

DRUG

WS016 Multiple Dose(24g)

WS016 24g, to be administered orally once daily for a consecutive period of 7 days.

DRUG

WS016 Multiple Dose(48g)

WS016 48g, to be administered orally once daily for a consecutive period of 7 days.

DRUG

MAD matching placebo

Matching placebo, to be administered orally once daily for a consecutive period of 7 days.

Trial Locations (1)

310000

Zhejiang Xiaoshan Hospital, Hangzhou

All Listed Sponsors
lead

Waterstone Pharmaceutical (Wuhan) Co., LTD.

INDUSTRY