NCT06281470

The Safety and Tolerability of WS016 in Healthy Chinese Volunteers

The First-in-Human, Single-Center, Randomized, Double-Blind, Placebo-Controlled，Single- and Multiple- Ascending Dose Study to Evaluate the Safety and Tolerability of WS016 in Healthy Chinese Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This clinic trial evaluates the safety and tolerability of single- and multiple- ascending doses of WS016 in healthy adult participants. There will be about 64 participants,48 active and 16 placebo.

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-13
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2024-02-28
• Last updated: 2024-02-28

Locations

1 site across 1 country: China