Clinical trials: Adalimumab
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
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
Bioequivalence, Phase 1
A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects
This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and tolerability of CinnoRA®, in a parallel fashion in healthy…
- Trial name
- NCT03273192
- Testing
- Adalimumab
- Where
- Iran
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Cinnagen
Pain, Injection Site
Adalimumab Microneedles in Healthy Volunteers
Adalimumab (Humira, AbbVie) is a highly effective treatment for a variety of auto-immune/auto-inflammatory diseases including juvenile idiopathic arthritis (JIA).
- Trial name
- NCT03607903
- Testing
- Adalimumab ID, Adalimumab SC, Saline ID
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Centre for Human Drug Research, Netherlands
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.
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
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
Plaque Psoriasis
The Safety & Efficacy of Etanercept in Psoriasis Patients Who Have Not Responded to Adalimumab
To describe the response of etanercept after adalimumab has failed to produce a satisfactory response in moderate to severe plaque psoriasis.
- Trial name
- NCT00833729
- Testing
- etanercept
- Where
- Canada
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Dermatrials Research
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 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
Chronic Granulomatous Disease, Crohn'S-like IBD
Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease
This study will determine if the drug infliximab is safe for treating inflammatory bowel disease (IBD) in patients with chronic granulomatous disease (CGD).
- Conditions
- Chronic Granulomatous Disease, Crohn'S-like IBD, Inflammatory Bowel Disease (IBD)
- Trial name
- NCT00325078
- Testing
- Infliximab
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Psoriasis
Evaluation of IL 12B Genetic Polymorphism (rs3213094)
Psoriasis is a skin disorder that is chronic proliferative and inflammatory in nature. Extensor surfaces, scalp, and lumbosacral area are covered in erythematous plaques with silvery scales.
- Trial name
- NCT07128472
- Testing
- Humira
- Where
- Egypt
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- South Valley University
Psoriasis
Regulatory T-cells in Psoriasis Patients as Targets for Therapy
The aim of this study is to understand which therapies will suppress effector cells and promote regulatory T cells and To test whether patients with a better response to therapy and longer psoriasis-free periods develop a higher…
- Trial name
- NCT01233583
- Testing
- Dovobet, neotigason, etanercept, adalimumab. infliximab
- Where
- United Kingdom
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- University of Aberdeen
Crohn's Disease, Ulcerative Colitis
The Effect of Infliximab on Sperm Quality
Background: The treatment of inflammatory bowel diseases (IBD) is based mainly on 3 compounds: 1- 5 aminosalysilates . 2- immunomodulators (Azathioprines). 3- Biologic therapies (Infliximab, Adalimumab) .
- Trial name
- NCT00745329
- Testing
- sperm quality test
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Tel-Aviv Sourasky Medical Center
Pharmacokinetics, Safety
Study to Compare PK & Safety of Advixa With Humira in Healthy, Adult Subject Followed by Efficacy & Safety Study in RA Patients
Adalimumab is a recombinant monoclonal antibody (IgG1 subclass) against human TNF-α (Tumor Necrosis Factor-alpha). It is an immunosuppressive medication predominantly used to treat rheumatoid arthritis autoimmune disease.
- Conditions
- Pharmacokinetics, Safety, Efficacy, Rheumatoid Arthritis
- Trial name
- ACT (NCT05172817)
- Testing
- Advixa (Adalimumab)
- Where
- Bangladesh
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Institute for Developing Science and Health Initiatives, Bangladesh
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
Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis
Rheumatoid arthritis (RA) is one of the most common inflammatory diseases in the general population and many cardiovascular diseases (valvular, myocardial, pericardial, coronary disease, stroke, heart failure etc.) have already…
- Trial name
- NCT01954381
- Testing
- transthoracic echocardiographic, Doppler ultrasound., blood samples
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Assistance Publique Hopitaux De Marseille
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.
Plaque Psoriasis
Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients
Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality.
- Trial name
- NCT06370156
- Testing
- Adalimumab
- Where
- Egypt
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Egymedicalpedia
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