Recruiting

Phase 1

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

Sponsor:

Novo Nordisk A/S

Code:

NCT07829406

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

NNC0642-1895

Placebo

Study Details

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

Study ID

NCT07829406

Start date

Sep 17, 2026

Status verified date

Oct, 2026

Completion date

Sep 12, 2027

Anticipated

Primary completion date

Sep 12, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NNC0642-1895

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

placebo comparator: Placebo

Participants will receive placebo matched to NNC0642-1895 intravenously.

Interventions

NNC0642-1895

NNC0642-1895 will be administered intravenously.

Placebo

Placebo will be administered intravenously.

Primary outcome measure

Number of treatment emergent adverse events (TEAE) [ Time Frame: From pre-dose (Day 1) to Day 66 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

ICON-Salt Lake City

Recruiting

Salt Lake City, Utah, United States, 84124

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.