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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohort A - XW014 | Active Comparator | Single oral XW014 administration |
|
| SAD Cohort A - Placebo | Placebo Comparator | Single oral placebo administration |
|
| MAD Cohort B - XW014 | Active Comparator | MAD in Healthy Subjects with Elevated BMI |
|
| MAD Cohort B - Placebo | Placebo Comparator | MAD in Healthy Subjects with Elevated BMI |
|
| MAD Cohort C - XW014 | Active Comparator | MAD in Patients with T2DM |
|
| MAD Cohort C - Placebo | Placebo Comparator | MAD in Patients with T2DM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XW014 | Drug | Oral tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE) | 11 weeks | |
| Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities | 11 weeks |
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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, inclusive, at screening
Age:
Body Mass Index
Patients with T2DM for at least 6 months, having HbA1c of 6.5% to 8.5% (Part C)
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Xu, MD | Sciwind Biosciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON - Early Development Services | Lenexa | Kansas | 66219 | United States | ||
| ICON - Early Development Services |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| MAD Cohort B-EXT - XW014 | Active Comparator | MAD in Healthy Subjects with Elevated BMI |
|
| MAD Cohort B-EXT - Placebo | Active Comparator | MAD in Healthy Subjects with Elevated BMI |
|
| Placebo |
| Drug |
Matched oral placebo tablets |
|
| XW014 | Drug | Oral capsules |
|
| Placebo | Drug | Matched oral placebo capsules |
|
| San Antonio |
| Texas |
| 78209 |
| United States |
| ICON - Early Development Services | Salt Lake City | Utah | 84124 | United States |
| D004700 | Endocrine System Diseases |