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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05184322




Registration number
NCT05184322
Ethics application status
Date submitted
21/12/2021
Date registered
11/01/2022

Titles & IDs
Public title
XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults
Scientific title
A Phase 1, Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ecnoglutide Tablet in Healthy Adult Participants
Secondary ID [1] 0 0
SCW0503-1011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - T2026
Treatment: Drugs - Placebo
Treatment: Drugs - Oral ecnoglutide tablet
Treatment: Drugs - Oral ecnoglutide tablet
Treatment: Drugs - Oral ecnoglutide tablet
Treatment: Drugs - Oral ecnoglutide tablet
Treatment: Drugs - Oral ecnoglutide tablet
Treatment: Drugs - Oral ecnoglutide tablet
Treatment: Drugs - T2026
Treatment: Drugs - Placebo
Treatment: Drugs - T2026
Treatment: Drugs - Placebo

Experimental: Cohort 1A/1B - Cohort 1A/1B will enroll 14 healthy participants.

Experimental: Cohort 2 - Cohort 2 will enroll 14 healthy participants.

Experimental: Cohort 3 - Cohort 3 will enroll 14 healthy participants.

Experimental: Cohort 4 - Cohort 4 will enroll 14 otherwise healthy participants with obesity.

Experimental: Cohort 5 - Cohort 5 will enroll 14 otherwise healthy participants with obesity.

Experimental: Cohort 6 - Cohort 6 will enroll 14 otherwise healthy participants with obesity.


Treatment: Drugs: T2026
Once daily for 15 days.

Treatment: Drugs: Placebo
Once daily for 15 days.

Treatment: Drugs: Oral ecnoglutide tablet
Once daily for 6 weeks.

Treatment: Drugs: Oral ecnoglutide tablet
Once daily and titrated up in concentration to once every week during maintenance period.

Treatment: Drugs: Oral ecnoglutide tablet
Once daily for 15 days.

Treatment: Drugs: Oral ecnoglutide tablet
Once daily for 15 days.

Treatment: Drugs: Oral ecnoglutide tablet
Once daily for 15 days.

Treatment: Drugs: Oral ecnoglutide tablet
Once daily for 15 days.

Treatment: Drugs: T2026
Once daily for 6 weeks.

Treatment: Drugs: Placebo
Once daily for 6 weeks.

Treatment: Drugs: T2026
Once daily to once weekly for 12 weeks.

Treatment: Drugs: Placebo
Once daily to once weekly for 12 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE)
Timepoint [1] 0 0
Up to 98 days

Eligibility
Key inclusion criteria
Key

* Healthy male or female participants, aged 18 to 55 years (inclusive at the time of informed consenting);
* Participants must be in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before administration of study drug;
* Stable body weight for at least 3 months prior to Screening (i.e., <5% change) by self-declaration;
* Participants must have a Body Mass Index (BMI) =22.0 kg/m2 and <32.0 kg/m2 and weigh =55 kg at Screening (Cohorts 1A/1B to 3), or participants must have a BMI =30.0 kg/m2 and <40.0 kg/m2 and weigh =75 kg at Screening (Cohort 4, 5 and 6 only);

Key
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product (IP) or procedures or interfere with study assessments;
* Confirmed diagnosis of diabetes mellitus type 1, type 2, or of any other forms at any time, and/or occurrence of documented or suspected hypoglycaemic episodes within 12 months prior to Screening;
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane) - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sciwind Biosciences APAC CO Pty. Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hangzhou Sciwind Biosciences Co., Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Sciwind Biosciences USA Co., Ltd.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Richard Friend
Address 0 0
Nucleus Network Brisbane Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Zhiyi (Alice) Zhu
Address 0 0
Country 0 0
Phone 0 0
+86-10-87126209
Fax 0 0
Email 0 0
zhiyi.zhu@sciwindbio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT05184322