The Safety and Tolerability of WS016 in Healthy Chinese Volunteers

February 19, 2024 updated by: Waterstone Pharmaceutical (Wuhan) Co., LTD.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Zhejiang Xiaoshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. The participants are fully informed of the purpose, methods and possible adverse reactions of the trial, and volunteer to serve as participants. And participants sign the informed consent form before any research procedures begin;
  2. Participants are healthy male or female volunteers between the ages of 18 and 45 (including the cut-off values);
  3. The weight of male participants is ≥50 kg, and the weight of female participants is ≥45 kg with a body mass index (BMI) of 19.0~26.0 kg/m^2 (including boundary values, BMI=weight (kg)/height^2 (m^2));
  4. The participants understand and comply with the study procedures, can communicate well with the researchers, volunteer to participate in the trial, and sign the informed consent form.

Exclusion Criteria:

  1. Participants with a specific allergy history (asthma, urticaria, eczema, etc.) or allergic constitution (e.g., known allergies to two or more substances), or known prior allergy to WS016 and related excipients;
  2. Participants with chronic diseases or severe diseases in the liver, kidney, digestive system, endocrine system, cardiovascular system, nervous system, metabolic system, blood system, respiratory system, and autoimmune system, or current diseases in these systems as judged by investigators to be unsuitable for inclusion;
  3. Participants who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the study period, as well as subjects who have undergone surgery that affects drug absorption, distribution, metabolism, and excretion;
  4. Participants with dysphagia or gastrointestinal diseases/symptoms judged by investigators to affect drug absorption;
  5. Participants who have received blood transfusions or used blood products ≥400 mL or 2 units within 3 months prior to screening, or have lost ≥400 mL of blood within 6 months, or have donated blood within 3 months;
  6. Participants who have used any prescription drugs (including vaccines), over-the-counter drugs within 4 weeks prior to screening;
  7. Pregnant or breastfeeding women, or participants with positive pregnancy test results before screening; male participants (or their partners) or female participants who have plans for pregnancy, sperm donation plans, or egg donation plans from the time they sign the informed consent form until 6 months after dosing; participants who are unwilling to use a medically recognized non-drug contraceptive method (e.g., intrauterine device or condom) during the study period;
  8. Participants with abnormal findings in physical examination, vital signs examination, electrocardiogram, laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation function), abdominal B-mode ultrasound examination, chest X-ray examination as judged by investigators to be clinically significant;
  9. Participants with positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) quantitative test, human immunodeficiency virus (HIV) quantitative test, and syphilis antibody test;
  10. Participants with a history of drug abuse within 12 months before screening, or urine drug screening positive results;
  11. Participants with positive results in alcohol breath testing, or participants who consume alcohol regularly within 3 months before screening (defined as an average of more than 14 units of alcohol per week, and 1 unit is approximately equal to 200 mL of beer with a 5% alcohol content, or 25 mL of strong liquor with a 40% alcohol content, or 85 mL of wine with a 12% alcohol content), or participants who cannot abstain from alcohol during the study period;
  12. Participants who are considered unsuitable for participation in this study by investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single Ascending Dose(SAD) Treatment 1
WS016 single dose（6g）
Drug: WS016 Single Dose(6g)
WS016 6g, to be administered orally as a single dose.
Experimental: SAD Treatment 2
WS016 single dose（12g）
Drug: WS016 Single Dose(12g)
WS016 12g, to be administered orally as a single dose.
Experimental: SAD Treatment 3
WS016 single dose（24g）
Drug: WS016 Single Dose(24g)
WS016 24g, to be administered orally as a single dose.
Experimental: SAD Treatment 4
WS016 single dose（36g）
Drug: WS016 Single Dose(36g)
WS016 36g, to be administered orally as a single dose.
Experimental: SAD Treatment 5
WS016 single dose（48g）
Drug: WS016 Single Dose(48g)
WS016 48g, to be administered orally as a single dose.
Placebo Comparator: SAD matching placebo
SAD Matching placebo
Drug: SAD matching placebo
Matching placebo, to be administered orally as a single dose.
Experimental: Multiple Ascending Dose(MAD) Treatment 1
WS016 multiple dose(MAD Low Dose)
Drug: WS016 Multiple Dose(12g)
WS016 12g, to be administered orally once daily for a consecutive period of 7 days.
Experimental: MAD Treatment 2
WS016 multiple dose(MAD Medium Dose)
Drug: WS016 Multiple Dose(24g)
WS016 24g, to be administered orally once daily for a consecutive period of 7 days.
Experimental: MAD Treatment 3
WS016 multiple dose(MAD High Dose)
Drug: WS016 Multiple Dose(48g)
WS016 48g, to be administered orally once daily for a consecutive period of 7 days.
Placebo Comparator: MAD matching placebo
Drug: MAD matching placebo
Matching placebo, to be administered orally once daily for a consecutive period of 7 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single- and multiple- ascending dose
Time Frame: up to Day 17
Incidence, severity and causality of AEs and SAEs
up to Day 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Waterstone Pharmaceutical (Wuhan) Co., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WS016-Ⅰ-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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