Recruiting
Phase 1
Study to Assess Tolerability of Injecting Larger Volumes (2-5 mL) Subcutaneously at Different Rates: Participant Experience and Acceptance
Condition(s) studied
Healthy Participants
Investigational drug(s) / intervention(s)
Syringe Pump
Syringe Pump: Device used for delivery of subcutaneous injections and infusions of NaCl solution.
Study summary
The purpose of the study is to investigate the tolerability of different injection/infusion volumes and speed compared to standard practise. The order in which the different volumes and injection speeds will be given to participants will be allocated by chance. Participants will be in this clinical study for about 1 week.
Eligibility
Inclusion criteria:
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Healthy male or female participants as judged by the investigator.
* Age 18-64 years (both inclusive) at the time of signing the informed consent.
* Body Mass Index (BMI) greater than or equal to (\>=) 18.5 and less than or equal to (\<=) 30.0 kilograms per square metre (kg/m\^2) (both included).
* White (Light skin that allows for adequate medical evaluation of any skin reactions).
Exclusion criteria:
* Known or suspected hypersensitivity to study intervention(s) or related products.
* Previous randomisation in this study.
* Previous rescreening for this study.
* Pregnant or breastfeeding female participants.
* Current participation (i.e., signed informed consent) in any other interventional clinical study. Treatment with an investigational medical product within 3 months or 5 half-lives (if known), whichever is longer prior to screening.
* Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol, including insufficient abdominal area for injection.
* Intake of any medication that could influence pain perception or injection site reaction appearance (e.g., anti-coagulants, including low dose of aspirin, systemic antihistamines, pain-relieving, or anti-inflammatory medicinal products) within the last week before the intervention.
* Intake of alcohol within the last 24 hours (self-reported) or a positive result of alcohol breath test prior to randomisation and intervention.
* Intake of illicit drugs within the last 48 hours (self-reported) or a positive result of urine drug screening prior to screening.
* Use of any nicotine products within the past month before screening.
* Known active or inactive skin condition or disease, tattoos, or other interventions in the injection area that may affect pain perception or assessment of injection-site reactions.
* Strenuous exercise within 3 days prior to the intervention.
Primary outcome measure(s)
- Injection pain rated on a Visual Analogue Scale (VAS) — 1 minute (±1 minute) from the injection initiation
The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in millimetres (mm).
- Injection pain rated on a VAS — 9 minutes (±1minute) from the injection initiation
The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in mm.
Trial sites (1)
| Facility | City | Region | Status |
| Novo Nordisk Clinical Innovation Centre A/S |
Gentofte Municipality |
Denmark |
Recruiting |
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