Back to resultsXW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
XW014
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Ability and willingness to participate in the study, give written informed consent, and comply with the study restrictions and all protocol procedures
- Sex: male or female
- Weight: >50 kg at screening
Age:
- For Part A 18 to 70 years, inclusive, at screening
- For Part B and C 18 to 55 years, inclusive, at screening
- Patients with T2DM for at least 6 months, having HbA1c of 6.5% to 8.5% (Part C)
Exclusion Criteria:
- History or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurologic, renal, pancreatic, immunologic, dermatologic, endocrine, genitourinary, or hematologic system
- Uncontrolled hypertension
- History of type 1 diabetes mellitus
- History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma
- Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the investigational product
Sites / Locations
- ICON - Early Development Services
- ICON - Early Development Services
- ICON - Early Development ServicesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
SAD Cohort A - XW014
SAD Cohort A - Placebo
MAD Cohort B - XW014
MAD Cohort B - Placebo
MAD Cohort C - XW014
MAD Cohort C - Placebo
Arm Description
Single oral XW014 administration
Single oral placebo administration
MAD in Healthy Subjects with Elevated BMI
MAD in Healthy Subjects with Elevated BMI
MAD in Patients with T2DM
MAD in Patients with T2DM
Outcomes
Primary Outcome Measures
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities
Secondary Outcome Measures
Full Information
NCT ID
NCT05579314
First Posted
September 27, 2022
Last Updated
August 14, 2023
Sponsor
Sciwind Biosciences USA Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05579314
Brief Title
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
Official Title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose Study to Assess Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sciwind Biosciences USA Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human (FIH) study to evaluate the safety, tolerability, food effect (FE), pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered XW014 in healthy participants and patients with T2DM. This study will consist of 3 parts: a Single Ascending Dose (SAD) part in healthy subjects (Part A), and Multiple Ascending Dose (MAD) parts in healthy subjects with elevated BMI (Part B) and patients with T2DM (Part C).
Detailed Description
Part A - SAD, including FE cohort: Healthy participants with BMI in the range of ≥18.5 kg/m2 to ≤35.0 kg/m2 will be randomized to receive a single oral dose of either XW014 or placebo in each of the planned SAD cohorts.
Part B - MAD in healthy participants with elevated BMI: Healthy subjects with BMI in the range of ≥30 kg/m2 to ≤40.0 kg/m2 will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.
Part C - MAD in patients with T2DM: Patients with T2DM for at least 6 months, having hemoglobin A1c (HbA1c) in the range of 6.5% to 8.5% will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SAD Cohort A - XW014
Arm Type
Active Comparator
Arm Description
Single oral XW014 administration
Arm Title
SAD Cohort A - Placebo
Arm Type
Placebo Comparator
Arm Description
Single oral placebo administration
Arm Title
MAD Cohort B - XW014
Arm Type
Active Comparator
Arm Description
MAD in Healthy Subjects with Elevated BMI
Arm Title
MAD Cohort B - Placebo
Arm Type
Placebo Comparator
Arm Description
MAD in Healthy Subjects with Elevated BMI
Arm Title
MAD Cohort C - XW014
Arm Type
Active Comparator
Arm Description
MAD in Patients with T2DM
Arm Title
MAD Cohort C - Placebo
Arm Type
Placebo Comparator
Arm Description
MAD in Patients with T2DM
Intervention Type
Drug
Intervention Name(s)
XW014
Intervention Description
Oral capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched oral placebo capsules
Primary Outcome Measure Information:
Title
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
Time Frame
11 weeks
Title
Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities
Time Frame
11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ability and willingness to participate in the study, give written informed consent, and comply with the study restrictions and all protocol procedures
Sex: male or female
Weight: >50 kg at screening
Age:
For Part A 18 to 70 years, inclusive, at screening
For Part B and C 18 to 55 years, inclusive, at screening
Patients with T2DM for at least 6 months, having HbA1c of 6.5% to 8.5% (Part C)
Exclusion Criteria:
History or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurologic, renal, pancreatic, immunologic, dermatologic, endocrine, genitourinary, or hematologic system
Uncontrolled hypertension
History of type 1 diabetes mellitus
History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma
Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the investigational product
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Adegbite
Email
info@sciwindbio.com
Facility Information:
Facility Name
ICON - Early Development Services
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Individual Site Status
Completed
Facility Name
ICON - Early Development Services
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Bass, JR, MD
Phone
210-283-4132
Email
robert.bass@iconplc.com
Facility Name
ICON - Early Development Services
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Ventrello
Phone
801-904-4636
Email
Christian.Ventrello@iconplc.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
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