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

Healthy Participants Clinical Trial

Official title:

A Comparative Bioavailability Study of a Single Dose of Ziltivekimab Formulation B in a Manual Syringe, Formulation D in a Manual Syringe and Formulation C in a Pen-injector

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05721989
• Other study ID #: NN6018-4951
• Secondary ID: 2022-001862-37U1
• Status: Completed
• Phase: Phase 1
• Start date: February 3, 2023
• Est. completion date: January 8, 2024

Study information

• Verified date: January 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: January 8, 2024
• Est. primary completion date: January 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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

Locations

Country	Name	City	State
Hungary	ICON Budapest Phase I Unit	Budapest
Netherlands	ICON - location Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Hungary,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-inf, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours and extrapolated to infinity after a single dose	Measured in day*microgram per milliliter (day*µg/mL).	From day 1 (pre-dose) to day 183 after a single dose
Secondary	Cmax, zilti, SD: Maximum observed ziltivekimab serum concentration after a single dose	Measured in micrograms per milliliters (µg/mL).	From day 1 (pre-dose) to day 183 after a single dose
Secondary	AUC0-183 days, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours to day 183 after a single dose	Measured in day*µg/mL.	From day 1 (pre-dose) to day 183 after a single dose
Secondary	tmax, zilti, SD: Time to maximum observed ziltivekimab serum concentration after a single dose	Measured in days.	From day 1 (pre-dose) to day 183 after a single dose
Secondary	t1/2, zilti, SD: Terminal half-life for ziltivekimab after a single dose	Measured in days.	From day 1 (pre-dose) to day 183 after a single dose
Secondary	Cl/F, zilti, SD: Apparent total serum clearance of ziltivekimab after a single dose	Measured in liters per day (L/day).	From day 1 (pre-dose) to day 183 after a single dose
Secondary	V/F, zilti, SD: Apparent volume of distribution of ziltivekimab after a single dose	Measured in liters (L).	From day 1 (pre-dose) to day 183 after a single dose
Secondary	AUC0-50 days, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours to 50 days after a single dose	Measured in day*µg/mL.	From day 1 (pre-dose) to day 50 after a single dose
Secondary	Cmax, 0-50 days, zilti, SD: Maximum observed ziltivekimab serum concentration after a single dose	Measured in µg/mL.	From day 1 (pre-dose) to day 50 after a single dose
Secondary	tmax, 0-50 days, zilti, SD: Time to maximum observed ziltivekimab serum concentration after a single dose	Measured in days.	From day 1 (pre-dose) to day 50 after a single dose