A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Subcutaneous Single Ascending Doses of NNC0650-0013 in Healthy Male Participants
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Participants
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- S.C. Cohort: Number of treatment emergent adverse events (TEAEs)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-55 years (both inclusive) at the time of signing the informed consent.
- •Body mass index between 24.0 and 29.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening.
- •Considered to be otherwise healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria
- •Any disorder, unwillingness or inability, which, in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- •Glycated haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole (mmol/mol)) at screening.
Arms & Interventions
Placebo
Participants will receive matching placebo to NNC0650-0013 subcutaneously.
Intervention: Placebo
NNC0650-0013: Subcutaneous dose
Participants will receive NNC0650-0013 subcutaneously in an ascending dose manner.
Intervention: NNC0650-0013 A
NNC0650-0013: Intravenous dose
Participants will receive NNC0650-0013 in an ascending dose manner intravenously.
Intervention: NNC0650-0013 A
Outcomes
Primary Outcomes
S.C. Cohort: Number of treatment emergent adverse events (TEAEs)
Time Frame: From time of dosing (day 1) until completion of the follow-up visit (day 75)
Measured as number of events.
Secondary Outcomes
- S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose(From pre-dose (day 1) until completion of the follow up visit (day 75))
- S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose(From pre-dose (day 1) until completion of the follow-up visit (day 75))
- S.C. and I.V. Cohort: AUC0-∞,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered(From pre-dose (day1) until completion of the follow-up visit (day 75))