Healthy ParticipantsPhase 1NCT06897813
A Phase I Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of WD-910 in Healthy Participants
A Phase 1 study testing WD-910 tablet in people with Healthy Participants, run by Zhejiang Wenda Pharma Technology LTD. at 1 site in Australia.
Trial summary
This is a phase I, randomised, double-blind, placebo-controlled, 3-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of WD-910 in in Healthy Participants Detailed Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- WD-910 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Jun 2025to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 55 years (inclusive) at the time of informed consent.
- Body mass index (BMI) between 18 to 32 kg/m2 and male participant with body weight of ≥ 50.0 kg, female participant with body weight ≥ 45.0 kg
Who cannot join
- Any major surgery within 12 weeks prior to Day 1, or any planned surgery during the study.
- Poor pill swallowing ability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
Joseph, +61 459 661 281, c.trollip@nucleusnetwork.com.au
About this study
This is a phase I, randomised, double-blind, placebo-controlled, 3-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of WD-910 in in Healthy Participants Detailed
- Conditions
- Healthy Participants
- Being tested
- WD-910 tablet, WD-910 Tablets Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WD-910 tabletDrug
Administered P.O.
WD-910 Tablets PlaceboDrug
Administered P.O.
| Study group | Role | What they receive |
|---|---|---|
| WD-910 Take a fixed dose of WD-910 tablets orally | Experimental | Not described Receives: Drug: WD-910 tablet |
| WD-910 Tablets Placebo Take a fixed dose of WD-910 tablets Placebo orally | Experimental | Not described Receives: Drug: WD-910 Tablets Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events (AEs)
Measured: A single-ascending dose (SAD) study ：up to 1week; multiple-ascending dose (MAD) study and food effect (FE) study : up to2weeks
Number of participants with abnormal lab values
Measured: SAD ：up to 1week; MAD and FE : up to2weeks
Single Ascending Dose Cohorts : Cmax
Measured: From Day1 to Day3
Single Ascending Dose Cohorts : AUC0-∞
Measured: From Day1 to Day3
Single Ascending Dose Cohorts : Tmax
Measured: From Day1 to Day3
Single Ascending Dose Cohorts : t½
Measured: From Day1 to Day3
Multiple Ascending Dose Cohorts: Cmax,ss
Measured: Day1 , Day10
Multiple Ascending Dose Cohorts: Cmin,ss
Measured: Day1 , Day10
Multiple Ascending Dose Cohorts: Cavg,ss
Measured: Day1 , Day10
Multiple Ascending Dose Cohorts: Tmax,ss
Measured: Day1 , Day10
Multiple Ascending Dose Cohorts: AUC0-τ
Measured: Day1 , Day10
Multiple Ascending Dose Cohorts: t½,
Measured: Day1 , Day10
Food Effect Cohorts: Cmax
Measured: From Day1 to Day4 ， From Day8 to Day11
Food Effect Cohorts: Tmax
Measured: From Day1 to Day4 ， From Day8 to Day11
Food Effect Cohorts: AUC0-t
Measured: From Day1 to Day4 ， From Day8 to Day11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Wenda Pharma Technology LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897813
- Sponsor's protocol ID
- WD-910-001
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of WD-910 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06897813
- Acronym / sponsor ID
- WD-910-001
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Zhejiang Wenda Pharma Technology LTD.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Mar 2025 (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 is a phase I, randomised, double-blind, placebo-controlled, 3-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of WD-910 in in Healthy Participants Detailed
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WD-910 Take a fixed dose of WD-910 tablets orally | Experimental | Drug: WD-910 tablet |
| WD-910 Tablets Placebo Take a fixed dose of WD-910 tablets Placebo orally | Experimental | Drug: WD-910 Tablets Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18 to 55 years (inclusive) at the time of informed consent.
- Body mass index (BMI) between 18 to 32 kg/m2 and male participant with body weight of ≥ 50.0 kg, female participant with body weight ≥ 45.0 kg
Key exclusion criteria (2 listed)
- Any major surgery within 12 weeks prior to Day 1, or any planned surgery during the study.
- Poor pill swallowing ability
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 |
|---|---|---|
| WD-910 tabletAdministered P.O. | Drug | WD-910 Take a fixed dose of WD-910 tablets orally |
| WD-910 Tablets PlaceboAdministered P.O. | Drug | WD-910 Tablets Placebo Take a fixed dose of WD-910 tablets Placebo orally |
Primary outcome
The incidence of adverse events (AEs)
Time frame: A single-ascending dose (SAD) study ：up to 1week; multiple-ascending dose (MAD) study and food effect (FE) study : up to2weeks
Number of participants with abnormal lab values
Time frame: SAD ：up to 1week; MAD and FE : up to2weeks
Single Ascending Dose Cohorts : Cmax
Time frame: From Day1 to Day3
Single Ascending Dose Cohorts : AUC0-∞
Time frame: From Day1 to Day3
Single Ascending Dose Cohorts : Tmax
Time frame: From Day1 to Day3
Single Ascending Dose Cohorts : t½
Time frame: From Day1 to Day3
Multiple Ascending Dose Cohorts: Cmax,ss
Time frame: Day1 , Day10
Multiple Ascending Dose Cohorts: Cmin,ss
Time frame: Day1 , Day10
Multiple Ascending Dose Cohorts: Cavg,ss
Time frame: Day1 , Day10
Multiple Ascending Dose Cohorts: Tmax,ss
Time frame: Day1 , Day10
Multiple Ascending Dose Cohorts: AUC0-τ
Time frame: Day1 , Day10
Multiple Ascending Dose Cohorts: t½,
Time frame: Day1 , Day10
Food Effect Cohorts: Cmax
Time frame: From Day1 to Day4 ， From Day8 to Day11
Food Effect Cohorts: Tmax
Time frame: From Day1 to Day4 ， From Day8 to Day11
Food Effect Cohorts: AUC0-t
Time frame: From Day1 to Day4 ， From Day8 to Day11
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Participants
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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.
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 WD-910 tablet in people with Healthy Participants, run by Zhejiang Wenda Pharma Technology LTD. at 1 site in Australia.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 2 Apr 2025. 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 Australia. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arockiaa Joseph (+61 459 661 281, c.trollip@nucleusnetwork.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (AEs) (time frame: A single-ascending dose (SAD) study ：up to 1week; multiple-ascending dose (MAD) study and food effect (FE) study : up to2weeks). The study lists 15 primary outcomes in all. 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 2 Apr 2025.