Clinical trials: Adalimumab
Healthy Subjects
A Study to Investigate How Well an Intracolonic Formulation of Two Monoclonal Antibodies is Tolerated in Healthy Participants and the Ability for the Antibodies to be Taken up by the Body Via the Colon
This is a proof-of-concept study to investigate whether antibodies (guselkumab and adalimumab) delivered directly to the colon can enter the systemic circulation.
- Trial name
- NCT07788807
- Testing
- Adalimumab, Guselkumab, SDL-001
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Surmount Services, Inc.
Healthy Volunteers
Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab)
This study has been designed as a multicentre, randomised, double-blind study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 compared to EU-Humira and US licenced Humira…
- Trial name
- NCT03849313
- Testing
- Adalimumab
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Healthy
Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and…
- Trial name
- NCT02395055
- Testing
- Adalimumab (BCD-057), Adalimumab (Humira)
- Where
- Russia
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Biocad
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
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
Healthy
Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)
This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union).
- Trial name
- NCT01870986
- Testing
- PF-06410293, Humira (adalimumab-EU), Humira (adalimumab-US)
- Where
- 2 sites in United States, Belgium
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects
The main purpose of the study is to demonstrate pharmacokinetic (PK) equivalence of PBP1502 to the European (EU) and American (US) Humira reference products, following a single subcutaneous (SC) dose of 40 mg in healthy…
- Trial name
- NCT05108259
- Testing
- PBP1502, EU-licensed Humira
- Where
- Spain
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Prestige Biopharma Limited
Healthy
A Study of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge
The purpose of the study is to characterize the inflammatory response to lipopolysaccharide (LPS; molecules that contains fats and carbohydrates) in the presence of a targeted immune pathway modulator.
- Trial name
- NCT05884242
- Testing
- Adalimumab, Lipopolysaccharide (LPS)
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Subjects
MSB11022 in Healthy Subjects
This is a phase I, randomized, double-blind, parallel-group trial to compare Investigation Medicinal Product (IMP) MSB11022, US- Reference Product (RP), and EU- Reference Medicinal Product (RMP) (Humira®) in healthy subjects.
- Trial name
- NCT03014947
- Testing
- MSB11022, US-licensed Humira, EU-approved Humira
- Volunteers
- 237 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Healthy Volunteers
Adalimumab PK Bioequivalence Study to EU and US Sourced Humira
Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of BMO-2 to EU and US Sourced Humira® Administered as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adults.
- Trial name
- NCT02472912
- Testing
- BMO-2, EU-Humira, US-Humira
- Where
- Belgium
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
Immune System Disorder
Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects
This healthy male volunteers study will evaluate 148 subjects who will receive a single sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or Adalimumab(Humira,China spourced,40 mg/0.8 mL injection…
- Trial name
- NCT03357939
- Testing
- HLX03, adalimumab
- Where
- China
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy Participants
Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects
This is a randomized, double-blind, two-arm, parallel group, single-dose study to demonstrate pharmacokinetic, safety, tolerability and immunogenicity similarity of biosimilar candidate TUR01 to EU-sourced Humira® in healthy…
- Trial name
- NCT04439929
- Testing
- TUR01, Adalimumab-EU
- Where
- Germany
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Turgut İlaçları A.Ş.
Pharmacokinetics, Safety Issues
A Clinical Study With Adalimumab Biosimilar
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs.
- Trial name
- NCT06291948
- Testing
- Humira® (adalimumab) AC Pen [Reference Product], Adalimumab Richmond [Test Product]
- Where
- Argentina
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Healthy Subjects
Pharmacokinetics and Safety Study of LBAL in Healthy Subjects
To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.
- Trial name
- NCT02206867
- Testing
- LBAL, Humira
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy Adult Male
A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects
The aim of this study is to establish comparability of pharmacokinetic parameters and similarity of the safety and immunogenicity profiles of single subcutaneous doses of BCD 057 100 mg/mL and BCD-057 50 mg/mL, as well as BCD-057…
- Trial name
- NCT07181694
- Testing
- Adalimumab (BCD-057) 100 mg/mL, Adalimumab (BCD-057) 50 mg/mL, Adalimumab (Humira) 100 mg/mL
- Where
- 4 sites in Russia
- Volunteers
- 444 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy Subjects
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))
This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to…
- Trial name
- B538-07 (NCT02237729)
- Testing
- PF-06410293, Adalimumab-US, Adalimumab-EU
- Where
- 8 sites in United States
- Volunteers
- 362 people, healthy volunteers welcome
- Sponsor
- Pfizer
Arthritis, Rheumatoid
Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects
This is a single site, parallel randomized, double blinded comparison of the safety, pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57 mg/kg dose of adalimumab (Humira®) reference product…
- Trial name
- NCT03254810
- Testing
- SYN060, Adalimumab North American source, Adalimumab European source
- Where
- Australia
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Synermore Biologics Co., Ltd.
Healthy
Comparative Clinical Trial to Evaluate Bioequivalency and Safety of Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and Adalimumab when used…
- Trial name
- NCT02912247
- Testing
- human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, adalimumab
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Adalimumab
A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants
To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the…
- Trial name
- NCT05909852
- Testing
- ABP 501-HCF, ABP 501-LCF
- Where
- 3 sites in United States
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Subjects
A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects
This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects
- Trial name
- B538-05 (NCT02572245)
- Testing
- PF-06410293 PFS, PF-06410293 PFP
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Pfizer