Route of administration Route of administration
Conditions
Interventions
Desmopressin (dilution of the nasal spray formulation) will be administered
intradermally
Sponsors
MyLife Technologies
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or non-pregnant female subjects, 18 to 65 years of age (inclusive). (Healthy status is defined by absence of evidence of any clinical significant/uncontrolled active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs,12-lead ECG, hematology, blood chemistry, serology and urinalysis); 2. Free of any polyuric disease (e.g., central diabetes insipidus), hemophilia or Von Willebrand disease; 3. Body mass index (BMI) between 18 and 35 kg/m2, inclusive; 4. Free of clinically significant systemic or dermatologic disorders, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Adverse Events; 5. If female of childbearing potential have a negative urine pregnancy test at Screening/Day 0, and is willing to use effective contraception during the study (i.e., oral, implanted, injectable, IUD, diaphragm, condom, tubal ligation, abstinence, or are in a monogamous relationship with a partner who has had a vasectomy); 6. Suitable site for intradermal injection, patch application on the arms, as assessed by the investigator; 7. Fitzpatrick skin type I-II (Caucasian); 8. Able to participate and willing to give written informed consent and to comply with the study restrictions; 9. Ability to communicate well with the investigator in the Dutch language;
Exclusion criteria
Exclusion criteria: Eligible subjects must meet none of the following exclusion criteria: 1. Any clinically significant abnormality as determined by medical history taking and physical examinations obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety; 2. Not willing to use effective (double barrier) contraception until at least 3 months after last study drug application; 3. For women: a positive pregnancy test and/or breastfeeding at screening or women who plan to become pregnant; 4. A positive test for drugs of abuse at screening; 5. History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption > 21 units/week); 6. Positive test results for Hepatitis B, Hepatitis C or HIV; 7. Have any current and / or recurrent clinical significant skin infection in the treatment area; 8. Have a known sensitivity to any of the investigational product ingredients; 9. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year; 10. Donation of blood or blood loss of >500 mL within 3 months prior to screening or donation of plasma within 14 days; 11. Not having a general practitioner; 12. Not willing to give permission to have the general practitioner to be notified upon participation in this study; 13. Any condition that in the opinion of the investigator would complicate or compromise the study or the well-being of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints Adverse events (AE) will be collected throughout the study, at every study visit. Vital signs and ECGs will be performed at every study visit. Urine collection for volume and osmolality will be collected during all treatment visits. Tolerability endpoints - Visual analogue scale for pain (VAS) ID administration vs. IM administration, vs. IV administration vs. patch administration - Examination of injection site by physician (erythema, swelling) - Grading for itching, pain - Skin barrier integrity by TEWL - Morphology by optical coherence tomography (OCT) Pharmacokinetic endpoints - Absolute Bioavailability - Maximum concentration - Time to maximum concentration - Plasma half-life - Area under the curve (AUC(0-24h), AUC(0-last)) | — |
Countries
Netherlands
Outcome results
None listed