Clinical trial NCT05579314: XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sciwind Biosciences USA Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility 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, 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

Primary outcomes:
measure: Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
timeFrame: 11 weeks
measure: Mean change from baseline in clinical laboratory values, vital signs, clinical findings from physical exam and ECG abnormalities
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON - Early Development Services
state: Kansas
city: San Antonio
country: United States
facility: ICON - Early Development Services
state: Texas
city: Salt Lake City
country: United States
facility: ICON - Early Development Services
state: Utah
Study officials:
affiliation: Sciwind Biosciences
name: Susan Xu, MD
role: STUDY_CHAIR
References: