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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-13

Study Completion Date

2025-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

GSK1349572 First Time in Human Study

NCT00555035

Healthy Subjects

COMPLETED PHASE1

First in Human Study of NI-0701 in Healthy Volunteers

NCT01255501

Healthy Volunteers

COMPLETED PHASE1

GSK706769 A First Time in Human Study For Males and Females

NCT00539201

Healthy Subjects

TERMINATED PHASE1

A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686

NCT00721812

Inflammatory Bowel Diseases

COMPLETED PHASE1

First-in-human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001

NCT02110420

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers Chronic Kidney Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A: NNC0705-0001

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

Group Type EXPERIMENTAL

NNC0705-0001

Intervention Type DRUG

NNC0705-0001 will be administered orally.

Part A: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching NNC0705-0001 will be administered orally.

Part B: NNC0705-0001

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

Group Type EXPERIMENTAL

NNC0705-0001

Intervention Type DRUG

NNC0705-0001 will be administered orally.

Part B: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching NNC0705-0001 will be administered orally.

Part C: NNC0705-0001

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.

Group Type EXPERIMENTAL

NNC0705-0001

Intervention Type DRUG

NNC0705-0001 will be administered orally.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NNC0705-0001

NNC0705-0001 will be administered orally.

Intervention Type DRUG

Placebo

Placebo matching NNC0705-0001 will be administered orally.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes