NCT01631942TerminatedPhase 1
A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Number of adverse events (AEs)
Study Overview
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.
Detailed Description
The present phase 1 trial has been terminated due to the need for changes in the trial design requiring a new re-designed multiple dosing phase 1 trial. Initiation of this new trial awaits additional non-clinical data.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •For haemophilia subjects only: Subjects diagnosed with haemophilia A with a baseline level of Factor VIII or Factor IX below 2% without inhibitors
Exclusion Criteria
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Thrombocyte count below the lower limit of normal range at screening
- •Any clinical signs or known history of thromboembolic events, or subject considered at high risk of thromboembolic events as judged by the investigator or subjects at increased risk of cardiovascular disease as judged by the investigator
Arms & Interventions
Low dose (healthy subjects)
Experimental
Intervention: NNC172-2021 (Drug)
Medium dose (subjects with haemophilia)
Experimental
Intervention: NNC172-2021 (Drug)
High dose (subjects with haemophilia)
Experimental
Intervention: NNC172-2021 (Drug)
Outcomes
Primary Outcomes
Number of adverse events (AEs)
Time Frame: From first trial drug administration through trial day 35
Secondary Outcomes
- Local tolerability(After the last s.c. dose administration (trial day 15))
- Thrombocyte count(After the last s.c. dose administration (trial day 15))
- Trough level (Ctrough)(Prior to the last s.c. dose administration (trial day 15))
Investigators
Study Sites (1)
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