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

NCT07029568 | Completed Phase 1

• 3 other identifiers: NN6705-8141U1111-1315-68422024-519478-38
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Volunteers; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (3)

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

  Measured in number of events.

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

• PART B: Number of TEAEs

  Measured in number of events.

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

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

  Measured in Hour x Micromole (hr×μM).

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

Secondary Outcomes (7)

• 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

  From pre-dose (day 1) to day 5

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

  From pre-dose (day 1) to day 5

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

  From pre-dose (day 1) to day 5

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

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

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

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

Study Arms (5)

Part A: NNC0705-0001

EXPERIMENTAL

Participants will receive 6 different single ascending doses of NNC0705-0001 via oral administration.

Drug: NNC0705-0001

Part A: Placebo

PLACEBO COMPARATOR

Participants will receive single ascending dose of placebo matching NNC0705-0001 via oral administration.

Drug: Placebo

Part B: NNC0705-0001

EXPERIMENTAL

Participants will receive 4 different multiple ascending doses of NNC0705-0001 via oral administration.

Drug: NNC0705-0001

Part B: Placebo

PLACEBO COMPARATOR

Participants will receive multiple ascending doses of placebo matching NNC0705-0001 via oral administration.

Drug: Placebo

Part C: NNC0705-0001

EXPERIMENTAL

Participants will receive 2 separate single doses of NNC0705-0001 at a previously safety-cleared dose level in PART A, either in a fed or fasted state.

Drug: NNC0705-0001

Interventions

NNC0705-0001 DRUG

NNC0705-0001 will be administered orally.

Part A: NNC0705-0001; Part B: NNC0705-0001; Part C: NNC0705-0001

Placebo DRUG

Placebo matching NNC0705-0001 will be administered orally.

Part A: Placebo; Part B: Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

ICON - location Groningen

Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: June 13, 2025
• Primary Completion: November 4, 2025
• Study Completion: December 10, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)