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The Safety and Tolerability of WS016 in Healthy Chinese Volunteers

NCT06281470 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-02-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Waterstone Pharmaceutical (Wuhan) Co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2023-06-15
Completion
2023-06-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06281470 on ClinicalTrials.gov