Healthy SubjectsPhase 1NCT06002555
Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation
A Phase 1 study testing Apraglutide in people with Healthy Subjects, run by VectivBio AG at 1 site in Netherlands.
Trial summary
This trial compares the relative bioavailability of apraglutide in dual-chamber syringes (DCS) versus the reference formulation apraglutide in vials. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Apraglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 May 2023to 22 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This trial compares the relative bioavailability of apraglutide in dual-chamber syringes (DCS) versus the reference formulation apraglutide in vials.
Read the detailed description
This is a single-center, open-label, randomized, three-period, and six-sequence cross-over trial with two washout periods of at least 14 days to compare the relative bioavailability of apraglutide using DCS versus the reference formulation in vials, following SC administrations in healthy male and female subjects.
Following consent, subjects will undergo a Screening procedure to see if they are suitable to be enrolled in the trial. Screening may be performed up to 28 days prior to the first injection procedure. All eligible subjects will receive the following treatments in three separate treatment periods:
- Treatment A: Single SC dose of 5 mg (400 µL) from DCS at a concentration of 12.5 mg/mL
- Treatment B: Two concomitant single SC doses of 2.5 mg (400 µL each) of DCS at a concentration of 6.25 mg/mL
- Treatment C: Single SC dose of 5 mg (200 µL) from vial at a concentration of 25 mg/mL of the current formulation-reference There will be a 14-day washout period between the first and second treatment periods and between the second and third treatment periods.
- Conditions
- Healthy Subjects
- Being tested
- Apraglutide
- Keywords
- Relative bioavailability, Dual-chamber syringe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApraglutideDrug
Peptide analogue of GLP-2
| Study group | Role | What they receive |
|---|---|---|
| Single SC dose of 5 mg from DCS | Experimental | Not described Receives: Drug: Apraglutide |
| Two concomitant single SC doses of 2.5 mg from DCS | Experimental | Not described Receives: Drug: Apraglutide |
| Single SC dose of 5 mg from vial | Active comparator | Not described Receives: Drug: Apraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma apraglutide primary PK parameter: Maximum observed plasma concentration (Cmax)
Measured: 0 to 312 hours post dose in each period
Plasma apraglutide primary PK parameter: AUCinf or AUClast
Measured: 0 to 312 hours post dose in each period
Secondary outcomes (13)
Time of maximum plasma concentration (tmax)
Measured: 0 to 312 hours post dose in each period
Terminal elimination rate constant (λz)
Measured: 0 to 312 hours post dose in each period
Terminal half-life (t½)
Measured: 0 to 312 hours post dose in each period
Incidence, nature and severity of adverse events (AE) with apraglutide
Measured: Baseline to Day 79
Clinical chemistry
Clinical Chemistry panel of analytes will be examined for clinically significant changes.
Clinical chemistry analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
Measured: Baseline to Day 79
Hematology
Hematology panel of analytes will be examined for clinically significant changes.
Hematology analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
Measured: Baseline to Day 79
Hemostasis
Hemostasis INR will be examined for clinically significant changes.
INR levels will be listed by subject. Descriptive statistics will be used to assess any changes in hemostasis results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
Measured: Baseline to Day 79
Anti-drug antibodies (ADA) analysis
ADA will be will be examined for clinically significant changes
Measured: Baseline to Day 79
Urine analysis
Urine analysis panel of analytes will be examined for clinically significant changes.
Urine analysis data will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
Measured: Baseline to Day 79
Occurrence of clinically relevant changes in electrocardiogram
ECG QT Interval
Measured: Baseline to Day 79
Occurrence of clinically relevant changes in electrocardiogram
ECG PR interval
Measured: Baseline to Day 79
Occurrence of clinically relevant changes in electrocardiogram
ECG QRS interval
Measured: Baseline to Day 79
Occurrence of clinically relevant changes in electrocardiogram
ECG rhythm
Measured: Baseline to Day 79
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start23 May 2023
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- VectivBio AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomasz Masior, Study director, VectivBio AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002555
- Sponsor's protocol ID
- TA799-018
- Status last verified
- Jan 2024
- First submitted
- 11 Jul 2023
- Last updated
- 26 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06002555
- Acronym / sponsor ID
- TA799-018
- Conditions
- Healthy Subjects
- Keywords
- Relative bioavailability, Dual-chamber syringe
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- VectivBio AGIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial compares the relative bioavailability of apraglutide in dual-chamber syringes (DCS) versus the reference formulation apraglutide in vials.
Detailed description
This is a single-center, open-label, randomized, three-period, and six-sequence cross-over trial with two washout periods of at least 14 days to compare the relative bioavailability of apraglutide using DCS versus the reference formulation in vials, following SC administrations in healthy male and female subjects.
Following consent, subjects will undergo a Screening procedure to see if they are suitable to be enrolled in the trial. Screening may be performed up to 28 days prior to the first injection procedure. All eligible subjects will receive the following treatments in three separate treatment periods:
- Treatment A: Single SC dose of 5 mg (400 µL) from DCS at a concentration of 12.5 mg/mL
- Treatment B: Two concomitant single SC doses of 2.5 mg (400 µL each) of DCS at a concentration of 6.25 mg/mL
- Treatment C: Single SC dose of 5 mg (200 µL) from vial at a concentration of 25 mg/mL of the current formulation-reference There will be a 14-day washout period between the first and second treatment periods and between the second and third treatment periods.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single SC dose of 5 mg from DCS | Experimental | Drug: Apraglutide |
| Two concomitant single SC doses of 2.5 mg from DCS | Experimental | Drug: Apraglutide |
| Single SC dose of 5 mg from vial | Active comparator | Drug: Apraglutide |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApraglutidePeptide analogue of GLP-2 | Drug | Single SC dose of 5 mg from DCS, Single SC dose of 5 mg from vial, Two concomitant single SC doses of 2.5 mg from DCS |
Primary outcome
Plasma apraglutide primary PK parameter: Maximum observed plasma concentration (Cmax)
Time frame: 0 to 312 hours post dose in each period
Plasma apraglutide primary PK parameter: AUCinf or AUClast
Time frame: 0 to 312 hours post dose in each period
13 secondary outcomes
Time of maximum plasma concentration (tmax)
Time frame: 0 to 312 hours post dose in each period
Terminal elimination rate constant (λz)
Time frame: 0 to 312 hours post dose in each period
Terminal half-life (t½)
Time frame: 0 to 312 hours post dose in each period
Incidence, nature and severity of adverse events (AE) with apraglutide
Time frame: Baseline to Day 79
Clinical chemistry
Time frame: Baseline to Day 79
Hematology
Time frame: Baseline to Day 79
Hemostasis
Time frame: Baseline to Day 79
Anti-drug antibodies (ADA) analysis
Time frame: Baseline to Day 79
Urine analysis
Time frame: Baseline to Day 79
Occurrence of clinically relevant changes in electrocardiogram
Time frame: Baseline to Day 79
Occurrence of clinically relevant changes in electrocardiogram
Time frame: Baseline to Day 79
Occurrence of clinically relevant changes in electrocardiogram
Time frame: Baseline to Day 79
Occurrence of clinically relevant changes in electrocardiogram
Time frame: Baseline to Day 79
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Masior study director
VectivBio AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apraglutide in people with Healthy Subjects, run by VectivBio AG at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma apraglutide primary PK parameter: Maximum observed plasma concentration (Cmax) (time frame: 0 to 312 hours post dose in each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.