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NNC0642-1895 for Healthy Subjects

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, NNC0642-1895, to assess its safety and behavior in the body. Participants will randomly receive either the new medicine or a placebo, which contains no active ingredients. The trial seeks healthy adults with a BMI between 18.5 and 29.9. The study will last about 14 weeks. As a Phase 1 trial, participants will be among the first to receive this treatment, contributing to understanding its effects in people.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that NNC0642-1895 is undergoing its first human trials, so no human data on its safety exists yet. However, safety data sheets provide some information about potential risks. The substance might cause allergic skin reactions and could irritate the eyes and breathing passages. It may also be harmful if swallowed.

As this is the first human trial, the primary goal is to assess the medicine's safety and tolerability in healthy adults. This phase is crucial for identifying any side effects or adverse reactions. Safety remains under evaluation at this stage, so by joining the trial, participants help researchers learn more about the treatment's safety.12345

Why do researchers think this study treatment might be promising?

Most treatments for various conditions depend on oral or topical administration, but NNC0642-1895 is unique because it's given intravenously, potentially allowing for faster and more efficient delivery directly into the bloodstream. Researchers are excited about NNC0642-1895 because it uses a novel active ingredient, NNC0537-1482, which may offer new therapeutic effects not seen with current standard treatments. This could lead to quicker results and possibly fewer side effects, offering a promising alternative to existing options.

What evidence suggests that this treatment could be effective?

Research is investigating the safety and behavior of NNC0642-1895 in the body after a single dose. In this trial, participants will receive either a single dose of NNC0642-1895 or a placebo. This treatment is new, and there is limited information on its effectiveness for any specific health issue. Current studies primarily aim to identify any side effects and how the body processes the medicine. Since this is the first human trial of NNC0642-1895, no data yet shows its ability to treat any health conditions. Further research is necessary to understand its potential benefits.6789

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not have any significant medical conditions. Participants should generally be in good health and able to follow study instructions.

Inclusion Criteria

Body Mass Index (BMI) between 18.5 to 29.9 kg/m^2 (both inclusive) at screening
Considered to be generally healthy based on medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory tests as judged by the investigator
My sex assigned at birth is male or female.
See 1 more

Exclusion Criteria

Heart rate outside 50-90 beats/min at screening
Known or suspected hypersensitivity to study intervention(s) or related products
Alanine aminotransferase (ALT) greater than Upper limit of normal (ULN) +10% at screening
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous dose of NNC0642-1895 or placebo

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics from Day 1 to Day 66

9 weeks
Multiple visits (in-person and/or virtual)

Extended Follow-up

Participants continue to be monitored for any long-term effects

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NNC0642-1895

Trial Overview

The study is testing a single dose of a new medicine called NNC0642-1895 compared to a placebo (inactive treatment). Which one you get is decided randomly. The main goal is to see if the new medicine is safe and how it acts in the body over about 14 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: NNC0642-1895Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

A Study to See How Safe a New Medicine (NNC0642-1895 ...

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.

A Study to See How Safe a New Medicine (NNC0642-1895) is ...

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.

Single Dose Safety and Body Response Assessment of ...

This study aims to evaluate the safety of a single dose of NNC0642-1895 by assessing the number of treatment emergent adverse events in healthy adults.

The efficacy and safety of β-nicotinamide mononucleotide ...

Our trial found that NMN supplementation has no effect on HOMA-IR of healthy adults. Similar results were also reported from two other human ...

Safety Data Sheet according to Regulation (EC) No 1907/ ...

Toxic to reproduction Category. May damage fertility. May damage the unborn child. Effects on or via lactation H362 May cause harm to breast-fed children.

SAFETY DATA SHEET Loctite Corporation

HAZARD IDENTIFICATION Irritating to eyes and respiratory system. Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Safety Data Sheet according to Regulation (EC) No 1907/ ...

Warning Hazard statement: H317 May cause an allergic skin reaction. Avoid breathing fumes given out during soldering. Flux fumes may irritate the nose, throat ...

Safety Data Sheet according to (EC) No 1907/2006 as ...

The substance or mixture is not hazardous. Avoid breathing fumes given out during soldering. eating, drinking or smoking. have low toxicity if swallowed.