Clinical trials: sponsored by Swedish Orphan Biovitrum
Rare Diseases
A Study to Evaluate Emapalumab in Japanese Healthy Volunteers.
This is a randomized, placebo controlled and double-blinded study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of a single dose (1 mg/kg) of emapalumab in adult healthy Japanese subjects.
- Trial name
- NCT04765553
- Testing
- NI-0501, Saline
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Healthy Volunteers
First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers
The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.
- Trial name
- NCT01459562
- Testing
- NI-0501
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Healthy
Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.
The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.
- Trial name
- NCT01857362
- Testing
- Nitisinone 20 mg, Nitisinone 10 mg
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Drug Drug Interaction
A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers
An open-label, non-randomized, 2-arm, 2-period fixed sequence phase 1 study to evaluate the potential inhibition of nitisinone on cytochrome P450 2C9, 2D6, and 2E1 and the organic anion transporters OAT1 and OAT3 in healthy…
- Trial name
- NCT03103568
- Testing
- Nitisinone in Arm A, Tolbutamide, Metoprolol
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Healthy
Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration
The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.
- Trial name
- NCT02083666
- Testing
- SOBI002
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Healthy Volunteers
Palifermin DDI (Drug Drug Interaction)
The purpose of this study is to determine if Paliferim interacts with Heparin.
- Trial name
- NCT00361348
- Testing
- Palifermin, Heparin
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Oral Mucositis
Study to Characterize the Effect of Heparin on Palifermin Activity
The purpose of this study is to evaluate the effect of a continuous intravenous infusion of unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult subjects.
- Trial name
- NCT01163097
- Testing
- Palifermin, Heparin
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Focus: Bioavailability
Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration
The main purpose of this study is to assess the relative bioavailability of Nascobal Nasal Spray as compared to an IM injection of cyanocobalamin (European reference product).
- Trial name
- NCT01306123
- Testing
- Nascobal nasal spray (cyanocobalamin, USP), Vitamin B12-ratiopharm N, injection solution
- Where
- Sweden
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Healthy Volunteers
Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension
The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation.
- Trial name
- NCT01682538
- Testing
- Nitisinone, capsule, Nitisinone, suspension
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum