A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults and in Participants With Hepatic Steatosis
Overview
- Phase
- Phase 1
- Intervention
- Placebo (NNC0581-0001)
- Conditions
- Healthy Volunteers
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Number of treatment emergent adverse events (TEAEs)
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581-0001 and explores the pharmacodynamics in healthy participants and participants with hepatic steatosis (increased liver fat). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance.NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Single Dose 4: NNC0581-0001 250 mg
Part A: Healthy participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.
Intervention: Placebo (NNC0581-0001)
Single Dose 1: NNC0581-0001 10 milligram (mg)
Part A: Healthy participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.
Intervention: NNC0581-0001
Single Dose 1: NNC0581-0001 10 milligram (mg)
Part A: Healthy participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.
Intervention: Placebo (NNC0581-0001)
Single Dose 2: NNC0581-0001 30 mg
Part A: Healthy participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.
Intervention: NNC0581-0001
Single Dose 2: NNC0581-0001 30 mg
Part A: Healthy participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.
Intervention: Placebo (NNC0581-0001)
Single Dose 3: NNC0581-0001 90 mg
Part A: Healthy participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.
Intervention: NNC0581-0001
Single Dose 3: NNC0581-0001 90 mg
Part A: Healthy participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.
Intervention: Placebo (NNC0581-0001)
Single Dose 4: NNC0581-0001 250 mg
Part A: Healthy participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.
Intervention: NNC0581-0001
Single Dose 5: NNC0581-001 600 mg
Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 600 mg or matching placebo injection subcutaneously.
Intervention: NNC0581-0001
Single Dose 5: NNC0581-001 600 mg
Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 600 mg or matching placebo injection subcutaneously.
Intervention: Placebo (NNC0581-0001)
Single Dose 6: NNC0581-001 1000 mg
Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 1000 mg or matching placebo injection subcutaneously.
Intervention: NNC0581-0001
Single Dose 6: NNC0581-001 1000 mg
Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 1000 mg or matching placebo injection subcutaneously.
Intervention: Placebo (NNC0581-0001)
Outcomes
Primary Outcomes
Number of treatment emergent adverse events (TEAEs)
Time Frame: From dosing (Day 1) until completion of the End of Study Visit at week 52
Measured as number of events.
Secondary Outcomes
- tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose(From dosing (Day 1) to 168 hours after dosing)
- AUC0-∞: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose(From dosing (Day 1) to 168 hours after dosing)
- Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose(From dosing (Day 1) to 168 hours after dosing)