Tolerability of Injecting Larger Volumes Subcutaneously at Different Speeds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial compares tolerability of subcutaneous injections given at varying volumes and infusion rates to standard practice. Participants will receive injections in a randomized order across a short, about 1-week study period. A syringe pump will be used to deliver the injections, and safety and participant experience will be monitored. Eligible participants are healthy adults aged 18–64 with BMI 18.5–30 and light skin tone, with several exclusion criteria to minimize risk.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novo Nordisk Clinical Innovation Centre A/S
  Gentofte Municipality, Denmark Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.