A Study to See How Safe a New Medicine (NNC6022-0004) is in Healthy People and People Living With Obesity

Официальное название

An NNC6022-0004 Single and Multiple Ascending Dose Study Investigating Safety, Tolerability, Pharmacokinetics, Food Effect and Target Engagement in Healthy Adults Including a Single Cohort in Adults Living With Obesity

Обзор

This study is being done to look at the efficacy single and multiple ascending dose study investigating safety, tolerability, pharmacokinetics, food effect and target engagement in healthy adults including a single cohort in adults living with obesity. Participants will either get NNC6022-0004, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.

Подробное описание

The study consists of 5 Parts (Parts A to E and the participants will be assessed based on the study intervention received (NNC6022-0004 or Placebo).

Вмешательства

• Препарат NNC6022-0004
  Participants will receive single dose of NNC6022-0004 administered orally in capsule form.
• Препарат Placebo
  Participants will receive placebo matched to NNC6022-0004 administered orally in capsule form.

Первичные конечные точки

• Part A: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose [Срок оценки: From pre-dose (Day 1) until visit 3 (Day 9)]
• Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose [Срок оценки: From pre-dose (Day 1) until visit 3 (Day 9)]
• Part B: Number of treatment emergent adverse events (TEAE) [Срок оценки: From time of dosing (Day 1) to end of study visit (Day 14)]
• Part C: Number of treatment emergent adverse events [Срок оценки: From time of dosing (Day 1) to end of study visit (Day 41)]
• Part D: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose [Срок оценки: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)]
• Part E: Number of treatment emergent adverse events [Срок оценки: From time of dosing (Day 1) to end of study visit (Day 13)]

Вторичные конечные точки (12)

• Part A: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose [Срок оценки: From pre-dose (Day 1) until visit 3 (Day 9)]
• Part A: Number of treatment emergent adverse events [Срок оценки: From time of dosing (Day 1) to end of study visit (Day 9)]
• Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose [Срок оценки: From pre-dose (Day 1) until visit 3 (Day 9)]
• Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose [Срок оценки: From pre-dose (Day 1) until visit 3 (Day 9)]
• Part B: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose [Срок оценки: From pre-dose (Day 1) until visit 3 (Day 9)]
• Part B: Proportion of administered dose recovered as unchanged drug in urine (Fe0-72h), calculated as Ae0-72hour/ dose [Срок оценки: From dose (Day 1) until 72h post-dose]
• Part C: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after the last dose [Срок оценки: From pre-dose (Day 28) to tau after last dose (Day 29)]
• Part C: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after last dose [Срок оценки: From pre-dose (Day 28) until visit 3 (Day 35)]
• Part C: interleukin β (IL-1β) (ex vivo): ratio of plasma level at time tau after last dose to baseline [Срок оценки: From pre-dose (Day 1) to tau after last dose (Day 29)]
• Part D: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose [Срок оценки: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)]
• Part D: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose [Срок оценки: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)]
• Part D: Number of treatment emergent adverse events [Срок оценки: From time of dosing (Day 1) to end of visit (Day 16)]

Критерии участия

Критерии включения

• Male, or female of non-childbearing potential.
• For Parts A, B, C and D: Age 18-55 years (both inclusive) at the time of signing the informed consent.

For optional Part E only: Age 18-65 years (both inclusive) at the time of signing the informed consent.

-For Parts A, B, C and D: Body mass index (BMI) between 18.5 to 29.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening.

For optional Part E only: BMI between greater than or equal to (≥) 30.0 to less than or equal to (≤) 45.0 kg/m\^2 at screening, or if BMI is between 27.0 and <30.0 kg/m\^2, waist to height ratio should be greater than (>)0.5.

• Body weight: ≥50.0 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.
• For optional Part E only: hsCRP ≥2.00 and ≤8.00 milligrams per liter (mg/L) during screening period in 2 separate samples taken ≥4 days apart.

Критерии исключения

• Known or suspected hypersensitivity to study intervention(s) or similar products.
• Any disorder, unwillingness or inability 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) > Upper limit of normal (ULN).
• Alkaline Phosphatase (ALP) > ULN.
• Aspartate aminotransferase (AST) > ULN.
• Total Bilirubin (TBL) > ULN.
• Creatinine > ULN.
• International normalized ratio (INR) > ULN.
• Fibrinogen outside normal range of 1.6 - 4.2 grams per liter (g/L).
• hsCRP > 5.00 mg/L (males) and > 8.00 mg/L (females)\*.

• applicable for Parts A, B, C and D and for optional Part E: hsCRP >8.00 mg/L.
• Use of prescription medicinal products or vaccines within 14 days before screening 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, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• ICON - location Groningen — Groningen

Идентификаторы

NCT: NCT07693868 · NN6022-8271 · U1111-1333-6460 · 2026-525179-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗