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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06897813




Registration number
NCT06897813
Ethics application status
Date submitted
4/03/2025
Date registered
27/03/2025

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
WD-910-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Participants 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - WD-910 tablet
Treatment: Drugs - WD-910 Tablets Placebo

Experimental: WD-910 Take a fixed dose of WD-910 tablets orally -

Experimental: WD-910 Tablets Placebo Take a fixed dose of WD-910 tablets Placebo orally -


Treatment: Drugs: WD-910 tablet
Administered P.O.

Treatment: Drugs: WD-910 Tablets Placebo
Administered P.O.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The incidence of adverse events (AEs)
Timepoint [1] 0 0
A single-ascending dose (SAD) study :up to 1week; multiple-ascending dose (MAD) study and food effect (FE) study : up to2weeks
Primary outcome [2] 0 0
Number of participants with abnormal lab values
Timepoint [2] 0 0
SAD :up to 1week; MAD and FE : up to2weeks
Primary outcome [3] 0 0
Single Ascending Dose Cohorts : Cmax
Timepoint [3] 0 0
From Day1 to Day3
Primary outcome [4] 0 0
Single Ascending Dose Cohorts : AUC0-8
Timepoint [4] 0 0
From Day1 to Day3
Primary outcome [5] 0 0
Single Ascending Dose Cohorts : Tmax
Timepoint [5] 0 0
From Day1 to Day3
Primary outcome [6] 0 0
Single Ascending Dose Cohorts : t½
Timepoint [6] 0 0
From Day1 to Day3
Primary outcome [7] 0 0
Multiple Ascending Dose Cohorts: Cmax,ss
Timepoint [7] 0 0
Day1 , Day10
Primary outcome [8] 0 0
Multiple Ascending Dose Cohorts: Cmin,ss
Timepoint [8] 0 0
Day1 , Day10
Primary outcome [9] 0 0
Multiple Ascending Dose Cohorts: Cavg,ss
Timepoint [9] 0 0
Day1 , Day10
Primary outcome [10] 0 0
Multiple Ascending Dose Cohorts: Tmax,ss
Timepoint [10] 0 0
Day1 , Day10
Primary outcome [11] 0 0
Multiple Ascending Dose Cohorts: AUC0-t
Timepoint [11] 0 0
Day1 , Day10
Primary outcome [12] 0 0
Multiple Ascending Dose Cohorts: t½,
Timepoint [12] 0 0
Day1 , Day10
Primary outcome [13] 0 0
Food Effect Cohorts: Cmax
Timepoint [13] 0 0
From Day1 to Day4 , From Day8 to Day11
Primary outcome [14] 0 0
Food Effect Cohorts: Tmax
Timepoint [14] 0 0
From Day1 to Day4 , From Day8 to Day11
Primary outcome [15] 0 0
Food Effect Cohorts: AUC0-t
Timepoint [15] 0 0
From Day1 to Day4 , From Day8 to Day11

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any major surgery within 12 weeks prior to Day 1, or any planned surgery during the study.
* Poor pill swallowing ability

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Zhejiang Wenda Medical Technology Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Arockiaa Joseph
Address 0 0
Country 0 0
Phone 0 0
+61 459 661 281
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06897813