Healthy VolunteersPhase 1NCT07829406
A Study to See How Safe a New Medicine (NNC0642-1895) is in Healthy People
A Phase 1 study testing NNC0642-1895 in people with Healthy Volunteers, run by Novo Nordisk A/S at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- NNC0642-1895
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2026to 12 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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%
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ICON-Salt Lake City
Salt Lake City, Utah, 84124
About this study
Official title: A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Intravenous Administrations of NNC0642-1895 in Healthy Adults
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
- Being tested
- NNC0642-1895, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0642-1895Drug
NNC0642-1895 will be administered intravenously.
PlaceboDrug
Placebo will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| NNC0642-1895 | Experimental | Participants will be administered a single dose of NNC0537-1482 intravenously. Receives: Drug: NNC0642-1895 |
| Placebo | Placebo comparator | Participants will receive placebo matched to NNC0642-1895 intravenously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAE)
Measured as number of events.
Measured: 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
Measured as nanomoles per liter hour (nmol/L*h).
Measured: From pre-dose (Day 1) to Day 66
Cmax; the observed maximum serum concentration of NNC0642-1895 after a single dose
Measured as nanomoles per liter (nmol/L).
Measured: From pre-dose (Day 1) to Day 66
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start17 Sep 2026
- Primary completion12 Sep 2027 (estimated)
- Study completion12 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829406
- Sponsor's protocol ID
- NN6642-7812
- Other IDs
- U1111-1303-3128
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisktrials.com
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Intravenous Administrations of NNC0642-1895 in Healthy Adults
- ClinicalTrials.gov ID
- NCT07829406
- Acronym / sponsor ID
- NN6642-7812
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 12 Sep 2027 (estimated)
- Study completion
- 12 Sep 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0642-1895 | Experimental | Drug: NNC0642-1895Participants will be administered a single dose of NNC0537-1482 intravenously. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to NNC0642-1895 intravenously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0642-1895NNC0642-1895 will be administered intravenously. | Drug | NNC0642-1895 |
| PlaceboPlacebo will be administered intravenously. | Drug | Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAE)
Time frame: From pre-dose (Day 1) to Day 66
Measured as number of events.
2 secondary outcomes
AUC0-∞; the area under the NNC0642-1895 serum concentration-time curve from time 0 to infinity after a single dose
Time frame: From pre-dose (Day 1) to Day 66
Cmax; the observed maximum serum concentration of NNC0642-1895 after a single dose
Time frame: From pre-dose (Day 1) to Day 66
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisktrials.com
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0642-1895 in people with Healthy Volunteers, run by Novo Nordisk A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment emergent adverse events (TEAE) (time frame: From pre-dose (Day 1) to Day 66). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.