Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous, Oral and Subcutaneous Doses of Inno8 in Healthy Male Participants
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This study will test how different doses of study medicine (Inno8) work in the healthy men. The purpose of this study is to prove safety of Inno8 in healthy men, which will support further development of Inno8 in people with Haemophilia A. The study consists of three parts: single ascending dose (SAD), multiple ascending dose (MAD) and single subcutaneous dose (SSD). Each part will have more than one cohort (like sub-parts). No matter which part the participants will be enrolled in, they will either get the study medicine (Inno8) or a dummy medicine that looks like the study medicine but has no effect on the body (placebo). Which treatment participants get is decided by chance. The study medicine is a new medicine that cannot be prescribed by doctors. In the SAD and SSD part participants will receive a single injection of study medicine or placebo, and the study will last for up to 9 weeks. In the MAD part, participants will receive 1-2 tablets of study medicine or placebo daily for 10 days, and the study will last for up to 11 weeks.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:
• Male
• Age 18-45 years (both inclusive) at the time of signing informed consent
• Body mass index between 18.5 and 29.9 Kilogram Per Square Meter (kg/m\^2) (both inclusive)
• Body weight between 60.0 and 100.0 Kilogram (kg) (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
Locations
Other Locations
Germany
Charité - Campus Charité Mitte - Charité Research Organisation GmbH
RECRUITING
Berlin
Charité Research Organisation GmbH
NOT_YET_RECRUITING
Berlin
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date:2024-09-23
Estimated Completion Date:2026-05-04
Participants
Target number of participants:108
Treatments
Experimental: Cohort 1 (SAD): NNC0442-0344 A
Participants will receive single dose of NNC0442-0344 A intravenously.
Experimental: Cohort 2 (SAD): NNC0442-0344 A
Participants will receive single dose of NNC0442-0344 A intravenously.
Experimental: Cohort 3 (SAD): NNC0442-0344 A
Participants will receive single dose of NNC0442-0344 A intravenously.
Experimental: Cohort 4 (SAD): NNC0442-0344 A
Participants will receive single dose of NNC0442-0344 A intravenously.
Experimental: Cohort 5 (SAD): NNC0442-0344 A
Participants will receive single dose of NNC0442-0344 A intravenously.
Experimental: Cohort 1 (MAD): NNC0442-0344 A
Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Experimental: Cohort 2 (MAD): NNC0442-0344 A
Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Experimental: Cohort 3 (MAD): NNC0442-0344 A
Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Experimental: Cohort 4 (MAD): NNC0442-0344 A
Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Experimental: Cohort 1 (SSD): NNC0442-0344 A
Participants will receive single dose of NNC0442-0344 A subcutaneously.
Experimental: Cohort 2 (SSD): NNC0442-0344 A
Participants will receive single dose of NNC0442-0344 A subcutaneously.
Placebo_comparator: SAD: Placebo
Participants will receive single dose of placebo intravenously.
Placebo_comparator: MAD: Placebo
Participants will receive a oral daily dose of Placebo for 10 days.
Placebo_comparator: SSD: Placebo
Participants will receive single dose of placebo subcutaneously.