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

NCT05579314 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2025-09-19

No results posted yet for this study

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).

Conditions

Interventions

DRUG

XW014

Oral tablets

DRUG

Placebo

Matched oral placebo tablets

DRUG

XW014

Oral capsules

DRUG

Placebo

Matched oral placebo capsules

Sponsors & Collaborators

  • Sciwind Biosciences USA Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Susan Xu, MD · Sciwind Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2024-11-16
Completion
2024-11-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05579314 on ClinicalTrials.gov