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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Chronic Kidney Disease; Healthy Volunteers

Treatments: Drug: Placebo; Drug: NNC0705-0001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07029568

2024-519478-38 (Other Identifier)

NN6705-8141

U1111-1315-6842 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 116 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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116 participants in 5 patient groups, including a placebo group

Part A: NNC0705-0001

Experimental group

Description:

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

Treatment:

Drug: NNC0705-0001

Part A: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Part B: NNC0705-0001

Experimental group

Description:

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

Treatment:

Drug: NNC0705-0001

Part B: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Part C: NNC0705-0001

Experimental group

Description:

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.

Treatment:

Drug: NNC0705-0001