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

Completed

• Conditions: Atherosclerotic cardiovascular disease; Cardiovascular disease; 10007510

• Registration Number: NL-OMON53876
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare the pharmacokinetic properties of a single s.c. administration of<br /><br>ziltivekimab in formulation B for the manual syringe, formulation D for the<br /><br>manual syringe, and formulation C for the pen-injector </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To compare the pharmacokinetic properties of a single s.c. administration of<br /><br>ziltivekimab in formulation B for the manual syringe, formulation D for the<br /><br>manual syringe, and formulation C for the pen-injector, 50 days following<br /><br>dosing</p><br>