CompletedPhase 1

Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation

A Randomized Open-label, Single Dose, 3-Period, 6-Sequence, Cross-Over Trial With Washout Periods of at Least 14 Days to Investigate the Relative Bioavailability of Apraglutide in Dual Chamber Syringes Versus the Reference Formulation in Vials Following Subcutaneous Administrations in Healthy Subjects

Lead sponsor

VectivBio AG

Asset

Apraglutide

Subcutaneous · GLP-2 receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 18-35

Primary endpoint

•Plasma apraglutide primary PK parameter

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06002555

Org study IDTA799-018

Timeline

Milestones

Study start2023-05-23actual

Study first posted2023-08-21actual

Primary completion2023-09-22actual

Study completion2023-09-22actual

Last update posted2024-10-26actual

Assets

Investigational agents

Apraglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age67 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Age between 18 and 67 years inclusive

•Subjects willing and able to comply with the study procedures

•Subjects able to understand and willing to sign the informed consent

•Body mass index (BMI) of ≥18.0 to ≤35.0 kg/m2; and a total body weight of >50 kg

•Women of childbearing potential (WOCBP) having undergone bilateral tubal occlusion or with vasectomized partner. Sterilized or infertile or postmenopausal females.

•Male subjects with a WOCBP partner using highly effective methods of contraception and agreeing on no sperm donation during the trial and for 4 weeks after (EOT) visit.

Exclusion criteria

•History of clinically significant gastrointestinal, bronchopulmonary, neurological, cardiovascular, endocrine, or allergic disease

•Known hypersensitivity to the investigational medicinal products (IMP), any of their excipients or drugs of the same class

•If capable of reproduction, unwilling to use an effective form of contraception

•If a WOCBP, a positive blood pregnancy test

•Breast-feeding women

•Positive urine/blood test for alcohol and drugs of abuse

•Use of prohibited medications or herbal remedies

•Known presence or history of intestinal polyps

•Known presence or history of any type of cancer

•Pancreatic events such as acute pancreatitis, pancreatic duct stenosis, pancreas infection, and increased blood amylase and lipase (>2.0-5.0× upper limit of normal range) at Screening or on Day -1 of each period

•Participation in an investigational drug or device study within 30 days prior to screening

•Donation of blood over 500 mL within 3 months prior to screening

•Use of tobacco products (i.e., smokes more than 10 cigarettes per day or equivalent)

•Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial

•Any intercurrent clinically significant illness in the previous 28 days before Day 1 of this study

•Positive blood screen for human immunodeficiency virus (HIV) antigen/antibody combo, hepatitis A (HAV IGM), hepatitis B surface antigen (HBsAgB), hepatitis B core antigen (anti-HBc) or hepatitis C virus (HCV)

•Unwillingness or inability to comply with the study protocol for any other reason

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

10 endpoints

Primary/protocol endpoint

Plasma apraglutide primary PK parameter: Maximum observed plasma concentration (Cmax)

Time frame:0 to 312 hours post dose in each period

concentration, descriptive

Primary/protocol endpoint

Plasma apraglutide primary PK parameter: AUCinf or AUClast

Time frame:0 to 312 hours post dose in each period

concentration, descriptive

Secondary/protocol endpoint

Time of maximum plasma concentration (tmax)

Time frame:0 to 312 hours post dose in each period

concentration, descriptive

Secondary/protocol endpoint

Terminal half-life (t½)

Time frame:0 to 312 hours post dose in each period

concentration, descriptive

Secondary/protocol endpoint

Incidence, nature and severity of adverse events (AE) with apraglutide

Time frame:Baseline to Day 79

descriptive

Secondary/protocol endpoint

Anti-drug antibodies (ADA) analysis

Time frame:Baseline to Day 79

descriptive

Secondary/protocol endpoint

Occurrence of clinically relevant changes in electrocardiogram

Time frame:Baseline to Day 79

descriptive

Secondary/protocol endpoint

Occurrence of clinically relevant changes in electrocardiogram

Time frame:Baseline to Day 79

descriptive

Secondary/protocol endpoint

Occurrence of clinically relevant changes in electrocardiogram

Time frame:Baseline to Day 79

descriptive

Secondary/protocol endpoint

Occurrence of clinically relevant changes in electrocardiogram

Time frame:Baseline to Day 79

descriptive