A Phase 1 interventional study of NNC 0172-0000-2021 and NNC 0172-0000-2021 in Congenital Bleeding Disorder, Haemophilia A and Haemophilia B, sponsored by Novo Nordisk A/S. Completed at 16 sites in 11 countries. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 52 is close to the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: NNC 0172-0000-2021
Drug: NNC 0172-0000-2021
Drug: placebo
Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose
Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.
Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.
Number of adverse Events (AEs), including Serious Adverse Events (SAEs)
Time frame: from trial product administration until 43 days after trial product administration
Area under the concentration-time curve
Time frame: from 43 days after trial product administration until 53 days after trial product administration
Adverse Events (AEs), including Serious Adverse Events (SAEs)
Time frame: from 43 days after trial product administration until 53 days after trial product administration
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S