XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05579314
• Other study ID #: XW014-001
• Status: Recruiting
• Phase: Phase 1
• Start date: September 26, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: Sciwind Biosciences USA Co., Ltd.
• Contact: Eric Adegbite
• Phone: 423-741-1084
• Email: info[@]sciwindbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 4 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 Part B-EXT) and patients with T2DM [Optional] (Part C).

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 and Part B-EXT - 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: March 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Ability and willingness to participate in the study, give written informed consent, and comply with the study restrictions and all protocol procedures

2. Sex: male or female

3. Weight: >50 kg, inclusive, at screening

4. Age:

1. For Part A 18 to 70 years, inclusive, at screening

2. For Part B, Part B-EXT, and C 18 to 55 years, inclusive, at screening

5. Body Mass Index

1. For Part A: =18.5 kg/m2 and =35.0 kg/m2, inclusive, at screening

2. For Part B and Part B-EXT: =30.0 kg/m2 and =40.0 kg/m2, inclusive, at screening

3. For Part C: =25.0 kg/m2 and =40.0 kg/m2, inclusive, at screening

6. Patients with T2DM for at least 6 months, having HbA1c of 6.5% to 8.5% (Part C)

Key Exclusion Criteria:

1. History or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurologic, renal, pancreatic, immunologic, dermatologic, endocrine, genitourinary, or hematologic system

2. Uncontrolled hypertension

3. History of type 1 diabetes mellitus

4. History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis

5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma

6. 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• XW014
Oral tablets
• Placebo
Matched oral placebo tablets
• XW014
Oral capsules
• Placebo
Matched oral placebo capsules

Locations

Country	Name	City	State
United States	ICON - Early Development Services	Lenexa	Kansas
United States	ICON - Early Development Services	Salt Lake City	Utah
United States	ICON - Early Development Services	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sciwind Biosciences USA Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)		11 weeks
Primary	Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities		11 weeks