A Study to See How Safe a New Medicine (NNC0642-1895) is in Healthy People

NCT07829406 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: NN6642-7812U1111-1303-3128
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing a new medicine, in healthy adults to assess its safety and understand how it behaves in the body. The purpose of this study is to evaluate the safety, tolerability, and how the body responds to a single dose of NNC0642-1895 in healthy adults. Participant will either get study medicine (NNC0642-1895) or placebo (a treatment that has no active medicine in it). Which treatment a participant receives is decided by chance. NNC0642-1895 is a new medicine that is being tested in humans for the first time and is not currently available for doctors to prescribe. The study will last for about 94 days (approximately 14 weeks).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAE)

  Measured as number of events.

  From pre-dose (Day 1) to Day 66

Secondary Outcomes (2)

• AUC0-∞; the area under the NNC0642-1895 serum concentration-time curve from time 0 to infinity after a single dose

  From pre-dose (Day 1) to Day 66

• Cmax; the observed maximum serum concentration of NNC0642-1895 after a single dose

  From pre-dose (Day 1) to Day 66

Study Arms (2)

NNC0642-1895

EXPERIMENTAL

Participants will be administered a single dose of NNC0537-1482 intravenously.

Drug: NNC0642-1895

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to NNC0642-1895 intravenously.

Drug: Placebo

Interventions

NNC0642-1895 DRUG

NNC0642-1895 will be administered intravenously.

NNC0642-1895

Placebo DRUG

Placebo will be administered intravenously.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female (sex assigned at birth, inclusive of all gender identities).
• Age 18-55 years (both inclusive) at the time of signing the informed consent.
• Body Mass Index (BMI) between 18.5 to 29.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening
• Considered to be generally 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.

You may not qualify if:

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
• Alanine aminotransferase (ALT) greater than (\>) Upper limit of normal (ULN) +10 percent (%)
• Aspartate aminotransferase (AST) \> ULN +20%
• Bilirubin \> ULN +20%
• Creatinine \> ULN +10%
• Absolute neutrophil count \> ULN
• Absolute neutrophil count less than (\<) Lower limit of normal (LLN)
• Platelet count \> ULN
• Platelet count \< LLN
• Supine blood pressure at screening outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic
• Heart rate outside the range of 50-90 beats/min at screening
• Use of prescription (except contraceptives) or non-prescription medicinal products within 14 days before screening. Occasional use of over-the-counter acetaminophen or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) at their labelled doses is permitted.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

ICON-Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 21, 2026
• Study Start: September 17, 2026
• Primary Completion (Estimated): September 12, 2027
• Study Completion (Estimated): September 12, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)