Skip to main content
OpenTrials
Completed

NCT Number: NCT07029568

A Study to See How Safe a New Medicine (NNC0705-0001) is in Healthy People

The study is testing a new study medicine (called NNC0705-0001), as a potential medicine to treat chronic systemic inflammation, which is known for increasing the risk of developing cardiometabolic diseases. The aim of this study is to see if the study medicine is safe, how it works in our body, and what our body does to the study medicine. The participant will either get NNC0705-0001 or placebo (a "dummy medicine" without the active ingredient). Which treatment the participant gets is decided by chance. The study consists of 3 parts: PART A - single ascending dose (SAD); PART B - multiple ascending doses (MAD) and PART C - food effect (FE) on the pharmacokinetic (PK) properties of NNC0705-0001 and will last about 35 days (PART A) and 41 days (PART B and C).

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men, or women of non-childbearing potential.
  • 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 meter square (kg/m^2) (both inclusive) at screening.
  • Body weight: greater than or equal to (≥) 50 kilogram (kg) 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 condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values; Alanine Aminotransferase (ALT) greater than (>) Upper limit of normal (ULN); Aspartate aminotransferase (AST) > ULN; Total Bilirubin (BIL) > ULN; Creatinine > ULN; International normalized ratio (INR) > ULN; High-Sensitivity C-Reactive Protein (hsCRP) > 5 milligram per liter (mg/L) (males) and > 8 mg/L (females)
  • Use of prescription medicinal products or vaccines within 14 days before dosing and/or non-prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over the counter paracetamol and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.

Treatment and study plan

NNC0705-0001

Drug

NNC0705-0001 will be administered orally.

Placebo

Drug

Placebo matching NNC0705-0001 will be administered orally.

Primary outcomes

  1. PART A: Number of treatment emergent adverse events (TEAE)

    Time frame: From time of dosing (day 1) to end of study (day 7)

    Measured in number of events.

  2. PART B: Number of TEAEs

    Time frame: From time of dosing (day 1) to end of study (day 13)

    Measured in number of events.

  3. AUC, SD; the area under the NNC0705-0001 plasma concentration-time curve after a single dose

    Time frame: From pre-dose (day 1 or day 8) to day 2 or day 9

    Measured in Hour x Micromole (hr×μM).

Secondary outcomes

  1. PART A: AUC0-t, SD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose

    Time frame: From pre-dose (day 1) to day 5

    Measured in hr×μM.

  2. PART A: AUC0-∞, SD; the area under the NNC0705-0001 plasma concentration-time curve from time 0 to infinity after a single dose

    Time frame: From pre-dose (day 1) to day 5

    Measured in hr×μM.

  3. PART A: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose

    Time frame: From pre-dose (day 1) to day 5

    Measured in micromole (μM).

  4. PART B: AUCtau, MD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to tau after the last dose

    Time frame: From pre-dose (day 7) to end of study (day 13)

    Measured in hr×μM.

  5. PART B: Cmax, MD; the maximum plasma concentration of NNC0705-0001 after last dose

    Time frame: From pre-dose (day 7) to end of study (day 13)

    Measured in μM.

  6. PART C: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose

    Time frame: From pre-dose (day 1 or day 8) to day 2 or day 9

    Measured in μM.

  7. PART C: Number of TEAEs

    Time frame: From time of dosing (day 1) to end of study (day 12)

    Measured in number of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Target Engagement of Single and Multiple Oral Administrations of NNC0705-0001 in Healthy Adults

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.