NNC0442-0344 A
DrugSAD: NNC0442-0344 A will be administered intravenously.
MAD: NNC0442-0344 A will be administered orally.
SSD: NNC0442-0344 A will be administered subcutaneously.
Other names: Inno8
NCT Number: NCT06649630
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.
Looking for future studies?
Notify Me18 year–45 year
Male
Interventional
Phase 1
Charité - Campus Charité Mitte - Charité Research Organisation GmbH, Berlin, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SAD: NNC0442-0344 A will be administered intravenously.
MAD: NNC0442-0344 A will be administered orally.
SSD: NNC0442-0344 A will be administered subcutaneously.
Other names: Inno8
SAD: Placebo will be administered intravenously.
MAD: Placebo will be administered orally.
SSD: Placebo will be administered subcutaneously.
Time frame: From time of dosing (Day 1) to Day 36
Measured as count of events.
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
Measured as count of events.
Time frame: From time of dosing (Day 1) to Day 36
Measured as count of events.
Time frame: From baseline (Day 1) to Day 36
Measured as absolute and percentage (%).
Time frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
Measured as nanograms per millilitre (ng/mL).
Time frame: From baseline (Day 1) to Day 36
Measured as nanograms*day per millilitre (ng*day/mL).
Time frame: From baseline (Day 1) to Day 36
Measured as days.
Time frame: From baseline (Day 1) to Day 36
Measured as seconds.
Time frame: From baseline (Day 1) to Day 36
Measured as nanomolar (nM).
Time frame: From baseline (Day 1) to Day 46
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 46
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 46
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 46
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 46
Measured as count.
Time frame: From Day 10 to Day 11
Measured as ng/mL.
Time frame: From Day 10 to Day 11
Measured as hours.
Time frame: From Day 1 to Day 2
Measured as hours.
Time frame: From Day 10 to Day 11
Measured as ng*day/mL.
Time frame: From Day 10 to Day 11
Measured as nM.
Time frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
Measured as absolute and %.
Time frame: From baseline (Day 1) to Day 36
Measured as ng/mL.
Time frame: From baseline (Day 1) to Day 36
Measured as ng*day/mL.
Time frame: From baseline (Day 1) to Day 36
Measured as days.
Time frame: From baseline (Day 1) to Day 36
Measured as seconds.
Time frame: From baseline (Day 1) to Day 36
Measured as nanomolar (nM).
Novo Nordisk A/S
Industry
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous, Oral and Subcutaneous Doses of Inno8 in Healthy Male Participants
Acronym: VOYAGER1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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