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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
127
ICON - Early Development Services
Lenexa, Kansas, United States
ICON - Early Development Services
San Antonio, Texas, United States
ICON - Early Development Services
Salt Lake City, Utah, United States
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
Time frame: 11 weeks
Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities
Time frame: 11 weeks
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Matched oral placebo capsules