HyperkalemiaPhase 1NCT06281470
The Safety and Tolerability of WS016 in Healthy Chinese Volunteers
A Phase 1 study testing WS016 Single Dose(6g), WS016 Single Dose(12g) and WS016 Single Dose(24g) in people with Hyperkalemia, run by Waterstone Pharmaceutical (Wuhan) Co., LTD. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- WS016 Single Dose(6g), WS016 Single Dose(12g) and WS016 Single Dose(24g)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2023to 15 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
- Participants are healthy male or female volunteers between the ages of 18 and 45 (including the cut-off values);
- 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));
- 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.
Who cannot join
- 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;
- 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;
- 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;
- Participants with dysphagia or gastrointestinal diseases/symptoms judged by investigators to affect drug absorption;
- 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;
- Participants who have used any prescription drugs (including vaccines), over-the-counter drugs within 4 weeks prior to screening;
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- 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;
- 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;
- 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;
- Participants with a history of drug abuse within 12 months before screening, or urine drug screening positive results;
- 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;
- Participants who are considered unsuitable for participation in this study by investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hyperkalemia
- Being tested
- WS016 Single Dose(6g), WS016 Single Dose(12g), WS016 Single Dose(24g), WS016 Single Dose(36g), WS016 Single Dose(48g)
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WS016 Single Dose(6g)Drug
WS016 6g, to be administered orally as a single dose.
WS016 Single Dose(12g)Drug
WS016 12g, to be administered orally as a single dose.
WS016 Single Dose(24g)Drug
WS016 24g, to be administered orally as a single dose.
WS016 Single Dose(36g)Drug
WS016 36g, to be administered orally as a single dose.
WS016 Single Dose(48g)Drug
WS016 48g, to be administered orally as a single dose.
SAD matching placeboDrug
Matching placebo, to be administered orally as a single dose.
WS016 Multiple Dose(12g)Drug
WS016 12g, to be administered orally once daily for a consecutive period of 7 days.
WS016 Multiple Dose(24g)Drug
WS016 24g, to be administered orally once daily for a consecutive period of 7 days.
WS016 Multiple Dose(48g)Drug
WS016 48g, to be administered orally once daily for a consecutive period of 7 days.
MAD matching placeboDrug
Matching placebo, to be administered orally once daily for a consecutive period of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose(SAD) Treatment 1 | Experimental | WS016 single dose（6g） Receives: Drug: WS016 Single Dose(6g) |
| SAD Treatment 2 | Experimental | WS016 single dose（12g） Receives: Drug: WS016 Single Dose(12g) |
| SAD Treatment 3 | Experimental | WS016 single dose（24g） Receives: Drug: WS016 Single Dose(24g) |
| SAD Treatment 4 | Experimental | WS016 single dose（36g） Receives: Drug: WS016 Single Dose(36g) |
| SAD Treatment 5 | Experimental | WS016 single dose（48g） Receives: Drug: WS016 Single Dose(48g) |
| SAD matching placebo | Placebo comparator | SAD Matching placebo Receives: Drug: SAD matching placebo |
| Multiple Ascending Dose(MAD) Treatment 1 | Experimental | WS016 multiple dose(MAD Low Dose) Receives: Drug: WS016 Multiple Dose(12g) |
| MAD Treatment 2 | Experimental | WS016 multiple dose(MAD Medium Dose) Receives: Drug: WS016 Multiple Dose(24g) |
| MAD Treatment 3 | Experimental | WS016 multiple dose(MAD High Dose) Receives: Drug: WS016 Multiple Dose(48g) |
| MAD matching placebo | Placebo comparator | MAD matching placebo Receives: Drug: MAD matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single- and multiple- ascending dose
Incidence, severity and causality of AEs and SAEs
Measured: up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start13 Feb 2023
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waterstone Pharmaceutical (Wuhan) Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281470
- Sponsor's protocol ID
- WS016-Ⅰ-01
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06281470
- Acronym / sponsor ID
- WS016-Ⅰ-01
- Conditions
- Hyperkalemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Waterstone Pharmaceutical (Wuhan) Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose(SAD) Treatment 1 | Experimental | Drug: WS016 Single Dose(6g)WS016 single dose（6g） |
| SAD Treatment 2 | Experimental | Drug: WS016 Single Dose(12g)WS016 single dose（12g） |
| SAD Treatment 3 | Experimental | Drug: WS016 Single Dose(24g)WS016 single dose（24g） |
| SAD Treatment 4 | Experimental | Drug: WS016 Single Dose(36g)WS016 single dose（36g） |
| SAD Treatment 5 | Experimental | Drug: WS016 Single Dose(48g)WS016 single dose（48g） |
| SAD matching placebo | Placebo comparator | Drug: SAD matching placeboSAD Matching placebo |
| Multiple Ascending Dose(MAD) Treatment 1 | Experimental | Drug: WS016 Multiple Dose(12g)WS016 multiple dose(MAD Low Dose) |
| MAD Treatment 2 | Experimental | Drug: WS016 Multiple Dose(24g)WS016 multiple dose(MAD Medium Dose) |
| MAD Treatment 3 | Experimental | Drug: WS016 Multiple Dose(48g)WS016 multiple dose(MAD High Dose) |
| MAD matching placebo | Placebo comparator | Drug: MAD matching placeboMAD matching placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
- Participants are healthy male or female volunteers between the ages of 18 and 45 (including the cut-off values);
- 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));
- 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.
Key exclusion criteria (12 listed)
- 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;
- 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;
- 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;
- Participants with dysphagia or gastrointestinal diseases/symptoms judged by investigators to affect drug absorption;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WS016 Single Dose(6g)WS016 6g, to be administered orally as a single dose. | Drug | Single Ascending Dose(SAD) Treatment 1 |
| WS016 Single Dose(12g)WS016 12g, to be administered orally as a single dose. | Drug | SAD Treatment 2 |
| WS016 Single Dose(24g)WS016 24g, to be administered orally as a single dose. | Drug | SAD Treatment 3 |
| WS016 Single Dose(36g)WS016 36g, to be administered orally as a single dose. | Drug | SAD Treatment 4 |
| WS016 Single Dose(48g)WS016 48g, to be administered orally as a single dose. | Drug | SAD Treatment 5 |
| SAD matching placeboMatching placebo, to be administered orally as a single dose. | Drug | SAD matching placebo |
| WS016 Multiple Dose(12g)WS016 12g, to be administered orally once daily for a consecutive period of 7 days. | Drug | Multiple Ascending Dose(MAD) Treatment 1 |
| WS016 Multiple Dose(24g)WS016 24g, to be administered orally once daily for a consecutive period of 7 days. | Drug | MAD Treatment 2 |
| WS016 Multiple Dose(48g)WS016 48g, to be administered orally once daily for a consecutive period of 7 days. | Drug | MAD Treatment 3 |
| MAD matching placeboMatching placebo, to be administered orally once daily for a consecutive period of 7 days. | Drug | MAD matching placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WS016 Single Dose(6g), WS016 Single Dose(12g) and WS016 Single Dose(24g) in people with Hyperkalemia, run by Waterstone Pharmaceutical (Wuhan) Co., LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.