Clinical trials: PFS
Healthy Volunteers
A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
The purpose of this study is to compare the PK of single dose of Vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03961308
- Testing
- Vedolizumab SC
- Where
- 2 sites in United States
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteer
A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers
This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers.
- Trial name
- NCT01418989
- Testing
- tocilizumab [RoActemra/Actemra] Syringe, tocilizumab [RoActemra/Actemra] auto-injector
- Where
- 2 sites in France
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
The purpose of this study is to compare PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03961295
- Testing
- Vedolizumab SC
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy, Multiple Sclerosis
Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers
The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or prefilled syringe (PFS) in healthy volunteers…
- Trial name
- NCT01610310
- Testing
- BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS), BIIB017 (peginterferon beta-1a) Autoinjector
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Biogen
Rheumatoid Arthritis
Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers
The purpose of this study was to compare the safety and pharmacokinetic characteristics of DWP422 25 mg with those of ENBREL 25MG PFS INJ. after subcutaneous injection in healthy male volunteers.
- Trial name
- NCT01635686
- Testing
- DWP422 25mg, ENBREL 25MG PFS INJ.
- Where
- South Korea
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy Volunteers
A Study of Marstacimab to Compare Prefilled Pen (PFP) Device to Prefilled Syringe (PFS) Device
The goal in this study is to show that there are not significant differences in biologic activity of the study drug when administered using either the prefilled pen and prefilled syringe.
- Trial name
- NCT04832139
- Testing
- Marstacimab PFP, Marstacimab PFS
- Where
- Belgium
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Pfizer
Controlled Ovarian Stimulation
To Compare and Evaluate the Efficacy and Safety of Ganilever PFS(Prefilled Syringe) and Orgalutran®
to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in infertility women for assisted reproductive technologies
- Trial name
- NCT03051087
- Testing
- Ganirelix acetate
- Where
- 2 sites in South Korea
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Infertile Women Undergoing IVF or ICSI
Observational Study to Develop Dosing Chart
To confirm the predictors based on patient specific characteristics and ovarian response and develop dosing chart when Follitrope™ PFS is administered to infertility women patients.
- Trial name
- NCT04227171
- Where
- South Korea
- Volunteers
- 534 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects
The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.
- Trial name
- NCT02326233
- Testing
- Pen of SB5, PFS of SB5
- Where
- 2 sites in Belgium, New Zealand
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis Co., Ltd.
Healthy Volunteers
A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03949621
- Testing
- Vedolizumab SC
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations.
- Trial name
- NCT01866007
- Testing
- Guselkumab (lyophilized formulation), Guselkumab (liquid formulation with PFS-U), Guselkumab (liquid formulation with PFS FID)
- Where
- 3 sites in United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteer
A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD)
This study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a…
- Trial name
- NCT02486809
- Testing
- Lebrikizumab
- Where
- 4 sites in United States
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK) profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe (PFS) as single subcutaneous (s.c.) injection…
- Conditions
- Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- Trial name
- NCT04018599
- Testing
- 40 mg MSB11022
- Where
- 2 sites in United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Phase 1
PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)
This study has been designed as a multicentre, randomised, open label study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in Pre-Filled Syringe compared to AVT02 in…
- Trial name
- NCT03983876
- Testing
- Adalimumab
- Where
- 2 sites in New Zealand
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Healthy Volunteers
A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)
This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD (reference device) in healthy participants.
- Trial name
- NCT02996019
- Testing
- Etrolizumab, Auto-Injector (AI), Prefilled Syringe With Needle Safety Device (PFS-NSD)
- Where
- 4 sites in United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Moderate to Severe Chronic Plaque Psoriasis
This is Comparative Study in Normal Healthy Subjects to Evaluate Pharmacokinetics, Safety, Tolerability of Bmab 1200 -Autoinjector (AI) After Single Subcutaneous Injection (45 mg) in Comparison With Bmab 1200 -Prefilled Syringe (PFS).
This is an open-label, 2-arm parallel-group study in normal healthy subjects to evaluate pharmacokinetics, safety, tolerability of Bmab 1200 -autoinjector (AI) after single subcutaneous injection (45 mg) in comparison with Bmab…
- Trial name
- NCT06738277
- Testing
- Bmab 1200 (Biosimilar Ustekinumab)
- Where
- India
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Biocon Biologics UK Ltd
Healthy Volunteers
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03948581
- Testing
- Vedolizumab SC
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Male Subjects
A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P52 in Healthy Male Subjects
This is phase 1 study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P52 in Healthy Male Subjects.
- Trial name
- NCT07367958
- Testing
- CT-P52
- Where
- South Korea
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Celltrion