Relative Bioavailability of Apraglutide in Prefilled Syringe versus Vial after Subcutaneous Injection in Healthy Subjects

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What is this study about?

The study involves healthy volunteers and evaluates a medication called apraglutide that is given as an injection under the skin (subcutaneous administration). The drug is being tested in two different packaging formats: a pre‑filled device known as dual chamber syringes and a traditional container called vials. Both formats contain the same amount of medication, but the way the drug is delivered may affect how it is absorbed into the body.

The purpose of the trial is to compare the bioavailability of the medication between the two delivery methods. Participants receive a single dose of the drug in each of three study periods, with a break of at least 14 days between periods to allow the previous dose to clear from the body (a “washout” period). During each period the same dose is given, but the format (syringe or vial) changes according to a set sequence.

Researchers will measure several blood‑level indicators, including the peak concentration of the drug (Cmax), which is the highest amount found in the blood, and the overall exposure over time (AUC), which reflects how much drug the body receives in total. Additional measurements such as the time when the peak occurs and how quickly the drug level declines (half‑life) will also be recorded to understand how the drug behaves after each type of administration.

1 baseline visit

after joining, you will attend a baseline visit where basic health measurements such as blood pressure, heart rate, and laboratory tests are taken to confirm eligibility.

the study staff will explain the schedule of the three dosing periods and the required washout periods.

2 first dose administration

you will receive a single 5 mg dose of apraglutide by subcutaneous injection using the formulation assigned for this period.

the injection is given in a clinical setting and you will be observed for a short time to monitor any immediate reactions.

3 first washout period

a washout period of at least 14 days follows, during which no study medication is taken.

you may continue normal activities but should avoid any other investigational drugs.

4 second dose administration

you will receive another single 5 mg dose of apraglutide by subcutaneous injection using the second formulation specified by the study sequence.

as before, the injection is given in the clinic and you will be observed for a short time.

5 second washout period

a second washout period of at least 14 days occurs, with no study medication taken.

6 third dose administration

you will receive the final single 5 mg dose of apraglutide by subcutaneous injection using the remaining formulation.

post‑injection observation is performed as in the previous periods.

7 final follow‑up and study completion

after the last dose, you will attend a final visit where additional safety checks and laboratory tests are performed.

the study team will thank you for participation and close the study records.

Who Can Join the Study?

Signed and dated Informed Consent Form (ICF) – you must sign a written form that explains the study before any study procedures are done.
Age between 18 and 67 years – you must be at least 18 years old and not older than 67 when you sign the consent form.
Body mass index (BMI) between 18 and 35 kg/m² – BMI is a measure of body weight relative to height; you must fall within this range.
Women who could become pregnant must agree to use a reliable birth‑control method during the study and for four weeks after the final visit.
Women who cannot become pregnant – this includes women whose partners have had a vasectomy, women who have had surgical sterilization (such as removal or blocking of the fallopian tubes, removal of the uterus, or removal of both ovaries), and post‑menopausal women.
Post‑menopausal women – defined as having no regular periods for at least 12 months, confirmed by low blood levels of the hormone estradiol and high levels of follicle‑stimulating hormone (FSH).
Men with a female partner who could become pregnant must use a highly effective birth‑control method (like condoms or partner’s vasectomy) and must not donate sperm during the study and for four weeks after the final visit; their partners must also use reliable birth control.
Willingness and ability to follow the study rules – you must be able to take part in all required visits and procedures and agree to follow the study instructions.
Good overall health – you must be judged healthy based on your medical history, a physical exam (including blood pressure, heart rhythm test called an ECG), and lab tests (blood chemistry, blood cell counts, urine test) that show no infection with HIV, hepatitis A, hepatitis B, or hepatitis C.

Who Cannot Join the Study?

Body weight must be between 50 kg and 110 kg; people lighter or heavier than this cannot join.
Pancreatic problems such as chronic or sudden inflammation of the pancreas (pancreatitis), a blocked pancreatic duct, pancreas infection, or high blood levels of the enzymes amylase and lipase (more than 2–5 times the normal range) at screening or the day before each study period will exclude you.
Having taken part in another drug or device study within the past 30 days before screening prevents participation.
Donating more than 499 mL of blood within the last 3 months before screening will exclude you.
Donating plasma within the last 2 weeks before screening will exclude you.
Heavy use of tobacco, defined as smoking more than 10 cigarettes per day at the time of screening, will exclude you.
Any other disease or condition that could interfere with the study or make it unsafe, as judged by the investigator, will exclude you.
A clinically important illness that occurred in the 28 days before the first day of the study, according to the investigator, will exclude you.
Positive test results for HIV (human immunodeficiency virus) or for hepatitis A, B, or C viruses will exclude you.
Being unwilling or unable to follow the study rules for any reason will exclude you.
A resting heart rate (pulse) while lying down that is less than 40 beats per minute or more than 100 beats per minute, or a blood pressure while lying down that is below 90/45 mmHg or above 140/90 mmHg at screening, will exclude you.
A history of serious digestive, liver, lung, nervous system, heart, hormone, kidney, allergy, or mental health problems, as judged by the investigator, will exclude you.
Any skin condition that could affect a subcutaneous (under‑the‑skin) injection or how injection reactions are interpreted will exclude you.
Regular alcohol use that exceeds 7 drinks per week for women or 14 drinks per week for men (one drink equals about a glass of wine, a bottle of beer, or a shot of liquor) within the last 3 months before screening will exclude you.
Any abnormal laboratory test result that does not match what is expected for a healthy person, as judged by the investigator, will exclude you.
Women who could become pregnant and have a positive pregnancy test will be excluded.
Breastfeeding women will be excluded.
Positive urine test for alcohol or illegal drugs at screening or the day before will exclude you.
Use of prohibited medicines, except for acetaminophen (paracetamol) up to 4 g per day for side‑effect treatment and hormonal birth‑control as specified, will exclude you.
Known presence or history of intestinal polyps (small growths in the lining of the intestine) will exclude you.
Known presence or history of any type of cancer will exclude you.

Where you can join this trial?

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Site Name	City	Country	Status
Pjsaydezhkmrja Rhsrwljj Arpbmkadow Gemhe Blwq	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	03.04.2023

Trial locations

Investigated Drugs:

Apraglutide

Apraglutide – This is an investigational medicine given as an injection under the skin. In this version it comes in a pre‑filled syringe that already contains the powder and the liquid needed to make the drug ready for use. The study uses this form to see how much of the drug reaches the bloodstream compared with the standard formulation.

Apraglutide – This form of the drug is supplied as a dry powder that must be mixed with a liquid before it can be injected. Participants will prepare the injection themselves, and the study will measure how well the drug is absorbed when given this way.

Apraglutide – This is another pre‑filled syringe version of the medication, containing both the powder and solvent together in a ready‑to‑use device. It is used in the trial to compare its absorption to the reference product and to the other test form.

Investigated Diseases:

Short-bowel syndrome

Healthy – A state of normal bodily function where the digestive system operates without disease or impairment. It remains stable unless challenged by illness or injury.

Trial ID:

2023-504430-22-00

Protocol code:

TA799-018

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Relative Bioavailability of Apraglutide in Prefilled Syringe versus Vial after Subcutaneous Injection in Healthy Subjects

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?