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

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sciwind Biosciences USA Co., Ltd.

Criteria

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 at screening

4. Age:

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

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

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

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