search
Back to results

XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults

Primary Purpose

Obesity, Type 2 Diabetes Mellitus

Status
Not yet recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
XW004
T2026
Placebo
Sponsored by
Sciwind Biosciences APAC CO Pty. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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;

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;

Sites / Locations

  • Q-Pharm Pty Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

T2026 tablet

Placebo tablet

Arm Description

Cohort 1 will enroll 10 healthy participants, doses ranging from 2mg to 7mg.

Cohort 2 will enroll 10 healthy participants, doses ranging from 2mg to 15mg.

Cohort 3 will enroll 10 healthy participants, doses ranging from 7mg to 30mg.

Cohort 4 will enroll 10 otherwise 'healthy' participants with obesity, doses ranging from 7mg to 30mg.

Tablet containing no ecnoglutide but T2026 2 participants receiving T2026 tablet will be enrolled in each cohort.

placebo containing no ecnoglutide or T2026 2 participants receiving placebo tablet will be enrolled in each cohort.

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events (TEAEs)
Count of adverse events

Secondary Outcome Measures

Maximum observed drug concentration
Calculated based on XW003 measured in blood.
Time of the maximum drug concentration
Calculated based on XW003 measured in blood
Maximum plasma concentration after last dosing
Calculated based on XW003 measured in blood
Change from Baseline in body weight
Percentage of body weight loss
Change from Baseline in fasting plasma glucose
Percentage of fasting plasma glucose change
Maximum observed drug concentration T2026
Calculated based on T2026 measured in blood.
Time of the maximum drug concentration T2026
Calculated based on T2026 measured in blood.
Maximum plasma concentration after last dosing T2026
Calculated based on T2026 measured in blood.
Incidence of anti-XW004 antibodies at end of study
Count of episodes

Full Information

First Posted
December 21, 2021
Last Updated
January 6, 2022
Sponsor
Sciwind Biosciences APAC CO Pty. Ltd.
Collaborators
Hangzhou Sciwind Biosciences Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05184322
Brief Title
XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sciwind Biosciences APAC CO Pty. Ltd.
Collaborators
Hangzhou Sciwind Biosciences Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
XW004 is an acylated human glucagon-like peptide 1 (GLP-1) analogue and is being developed for type 2 diabetes mellitus (T2DM) and obesity management.
Detailed Description
This is a single-centre, double-blind, randomised, multiple ascending dose, placebo-controlled study including four cohorts. All cohorts will have treatment regimens consisting of 15-day once daily dosing and a follow-up visit 21 days after last dosing. Participants will undergo a Screening period beginning up to 28 days prior to randomisation/dose administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes Mellitus
Keywords
Obesity, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This is a single centre, double-blind, randomised, multiple-dose, placebo-controlled study, including four cohorts (Cohorts 1, 2, 3, and 4) .
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Cohort 1 will enroll 10 healthy participants, doses ranging from 2mg to 7mg.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Cohort 2 will enroll 10 healthy participants, doses ranging from 2mg to 15mg.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Cohort 3 will enroll 10 healthy participants, doses ranging from 7mg to 30mg.
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Cohort 4 will enroll 10 otherwise 'healthy' participants with obesity, doses ranging from 7mg to 30mg.
Arm Title
T2026 tablet
Arm Type
Experimental
Arm Description
Tablet containing no ecnoglutide but T2026 2 participants receiving T2026 tablet will be enrolled in each cohort.
Arm Title
Placebo tablet
Arm Type
Placebo Comparator
Arm Description
placebo containing no ecnoglutide or T2026 2 participants receiving placebo tablet will be enrolled in each cohort.
Intervention Type
Drug
Intervention Name(s)
XW004
Other Intervention Name(s)
GLP-1 analogue
Intervention Description
2, 7, 15, 30mg tablets once daily for 15 days.
Intervention Type
Drug
Intervention Name(s)
T2026
Other Intervention Name(s)
Absorption enhancer
Intervention Description
Once daily for 15 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily for 15 days.
Primary Outcome Measure Information:
Title
Number of treatment emergent adverse events (TEAEs)
Description
Count of adverse events
Time Frame
36 days
Secondary Outcome Measure Information:
Title
Maximum observed drug concentration
Description
Calculated based on XW003 measured in blood.
Time Frame
36 days
Title
Time of the maximum drug concentration
Description
Calculated based on XW003 measured in blood
Time Frame
36 days
Title
Maximum plasma concentration after last dosing
Description
Calculated based on XW003 measured in blood
Time Frame
36 days
Title
Change from Baseline in body weight
Description
Percentage of body weight loss
Time Frame
36 days
Title
Change from Baseline in fasting plasma glucose
Description
Percentage of fasting plasma glucose change
Time Frame
36 days
Title
Maximum observed drug concentration T2026
Description
Calculated based on T2026 measured in blood.
Time Frame
36 days
Title
Time of the maximum drug concentration T2026
Description
Calculated based on T2026 measured in blood.
Time Frame
36 days
Title
Maximum plasma concentration after last dosing T2026
Description
Calculated based on T2026 measured in blood.
Time Frame
36 days
Title
Incidence of anti-XW004 antibodies at end of study
Description
Count of episodes
Time Frame
36 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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; 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HONG QIN
Phone
(+86)13679290113
Email
hong.qin@sciwindbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Friend
Organizational Affiliation
Nucleus Network Brisbane Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Q-Pharm Pty Ltd
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Wong
Phone
+61 402 329 162
Email
E.Wong@nucleusnetwork.com.au
First Name & Middle Initial & Last Name & Degree
Richard Friend

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults

We'll reach out to this number within 24 hrs