Clinical trial NCT05184322: XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults
Official title: A Phase 1, Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ecnoglutide Tablet in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Obesity
Type 2 Diabetes Mellitus
Keywords: Obesity
Type 2 Diabetes Mellitus
Lead sponsor: Sciwind Biosciences APAC CO Pty. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Hangzhou Sciwind Biosciences Co., Ltd.
name: Sciwind Biosciences USA Co., Ltd.
First posted: 2022-01-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single centre, double-blind, randomised, multiple-dose, placebo-controlled study, including six cohorts (Cohorts 1A/1B, 2, 3, 4, 5, 6) with a semi-parallel design.
Primary purpose: TREATMENT

Brief summary: XW004 is an acylated human glucagon-like peptide 1 (GLP-1) analogue and is being developed for type 2 diabetes mellitus (T2DM) and obesity management.

Detailed description: This is a single centre, double-blind, randomised, multiple-dose, placebo-controlled study, including six cohorts (Cohorts 1A/1B, 2, 3, 4, 5, 6) with a semi-parallel design. The study is designed to evaluate the safety, tolerability, PK, and PD of oral ecnoglutide tablet in healthy participants. Participants will undergo a Screening period beginning up to 28 days (Cohort 1 to 4) and 42 days (Cohort 5 and 6 ) prior to randomisation/dose administration and will be required to sign an informed consent form (ICF) before undertaking any study specific procedures or assessments. Participants who meet all of the inclusion and none of the exclusion criteria will be enrolled. Eligible participants will be admitted to the CRU on Day -1 for review of inclusion and exclusion criteria prior to the start of study procedures on Day 1. A Safety Review Committee (SRC) will be established to monitor the progress of this trial and to make recommendations on whether to continue, modify or stop the trial for safety or ethical reasons.

Eligibility criteria: Key Inclusion Criteria:

* Healthy male or female participants, aged 18 to 55 years (inclusive at the time of informed consenting);
* Participants must be in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before administration of study drug;
* Stable body weight for at least 3 months prior to Screening (i.e., \<5% change) by self-declaration;
* Participants must have a Body Mass Index (BMI) ≥22.0 kg/m2 and \<32.0 kg/m2 and weigh ≥55 kg at Screening (Cohorts 1A/1B to 3), or participants must have a BMI ≥30.0 kg/m2 and \<40.0 kg/m2 and weigh ≥75 kg at Screening (Cohort 4, 5 and 6 only);

Key Exclusion Criteria:

* Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product (IP) or procedures or interfere with study assessments;
* Confirmed diagnosis of diabetes mellitus type 1, type 2, or of any other forms at any time, and/or occurrence of documented or suspected hypoglycaemic episodes within 12 months prior to Screening;
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;

Primary outcomes:
measure: Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE)
timeFrame: Up to 98 days
Secondary outcomes:
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane)
state: Queensland
Study officials:
affiliation: Nucleus Network Brisbane Clinic
name: Richard Friend
role: PRINCIPAL_INVESTIGATOR
References: