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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

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 - Comparative bioavailability study of ziltivekimab formulation B, D and C

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53876
Enrollment
200
Registered
2023-01-09
Start date
2023-02-03
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic cardiovascular disease Cardiovascular disease

Interventions

The volunteer will be given ziltivekimab as an injection under the skin (subcutaneous) of the abdomen. There are 3 different study treatments in this study. The volunteer will receive 1 of them. W

Sponsors

Novo Nordisk A/S
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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 kg/m2 (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

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, as defined in section 10.4. - 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.

Design outcomes

Primary

MeasureTime frame
To compare the pharmacokinetic properties of a single s.c. administration of ziltivekimab in formulation B for the manual syringe, formulation D for the manual syringe, and formulation C for the pen-injector

Secondary

MeasureTime frame
To compare the pharmacokinetic properties of a single s.c. administration of ziltivekimab in formulation B for the manual syringe, formulation D for the manual syringe, and formulation C for the pen-injector, 50 days following dosing

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)