A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Ziltivekimab C; Drug: Ziltivekimab D; Drug: Ziltivekimab B

Study type: Interventional

Funder types: Industry

Identifiers

NCT05721989

2022-001862-37 (EudraCT Number)

U1111-1277-3676 (Other Identifier)

NN6018-4951

Details and patient eligibility

About

A research study to investigate how quickly and to what extent different compositions of the study medicine ziltivekimab are absorbed, transported, and eliminated from the body. Ziltivekimab is not yet approved for market. The study medicine will be injected under the skin (this is called subcutaneous administration). Two different administration methods will be compared: a syringe and a pen-injector. A pen-injector is a device that is developed to make injections more easy and convenient. They are for example used by diabetes patients to inject insulin. It will also be investigated how safe ziltivekimab is and how well it is tolerated when it is used by healthy participants. Ziltivekimab has already been administered to patients with chronic kidney disease or rheumatoid arthritis. The current study will be the first study where ziltivekimab will be given to healthy participants.

Enrollment: 267 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female
• Aged 18-64 years (both inclusive) at the time of signing informed consent.
• Body mass index (BMI) between 18.5 and 29.9 kilograms per square meter (kg/m^2) (both inclusive).
• 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.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
• Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, acetylsalicylic acid within 14 days before trial product administration.
• Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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267 participants in 3 patient groups

Ziltivekimab B (manual syringe)

Experimental group

Description:

Participants will receive a single subcutaneous (s.c.) injection of 15 milligram (mg) ziltivekimab B (15 milligrams per milliliter \[mg/mL\]) by single-use pre-filled manual syringe on Day 1.

Treatment:

Drug: Ziltivekimab B

Ziltivekimab D (manual syringe)

Experimental group

Description:

Participants will receive a single s.c. injection of 15 mg ziltivekimab D (15 mg/mL) by single-use pre-filled manual syringe on Day 1.

Treatment:

Drug: Ziltivekimab D

Ziltivekimab C (pen-injector)

Experimental group

Description:

Participants will receive a single s.c. injection of 15 mg ziltivekimab C (30 mg/mL) by single-use pre-filled syringe assembled into a shield-activated pen-injector on Day 1.

Treatment:

Drug: Ziltivekimab C