Actively Recruiting
To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects
Led by Prestige Biopharma Limited · Updated on 2025-05-31
324
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 volunteers.
CONDITIONS
Official Title
To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female adults aged 18 to 55 years inclusive
- Able to understand the study purpose, risks, and provide written informed consent
- Body mass index between 18.0 and 32.0 kg/m2 inclusive
- Subject and partner of childbearing potential agree to use highly effective contraception throughout the study and for 5 months after treatment
- Menopausal females must have had their last period over 1 year prior to consent
You will not qualify if you...
- History or current clinically significant allergies or hypersensitivity to study drug components or related proteins
- Known active hepatitis B, hepatitis C, or HIV infection (resolved hepatitis B allowed)
- History of invasive fungal or opportunistic infections, or herpes zoster
- Significant cardiac, gastrointestinal, renal, endocrine, neurological, autoimmune, hepatic, hematological, metabolic, or pulmonary diseases
- History of any cancer
- Recent systemic or local infection or inflammation within 2 months prior to screening
- Elevated C-reactive protein above 1.5 times the upper limit of normal
- Impaired liver function with elevated liver enzymes or bilirubin
- Significant abnormal cardiac function by investigator judgment
- Surgery within 4 weeks prior to dosing or planned during study
- Active or latent tuberculosis or recent close contact with active tuberculosis
- Pregnant, lactating, or planning pregnancy or breastfeeding during study and for 5 months after dosing
- Male planning to father a child or donate sperm during study and for 5 months after dosing
- Prior monoclonal antibody or fusion protein treatment within 9 months, or current biologic use, including prior adalimumab exposure
- Treatment with biological or immunosuppressive agents (excluding monoclonal antibodies) within 3 months prior to screening
- Use of medications or supplements that may affect study outcomes within 2 weeks prior to dosing
- Participation in another clinical study or investigational drug use within 90 days prior to dosing
- Live or live-attenuated vaccine within 4 weeks prior to dosing or planned within 6 months after dosing
- Significant recent blood donation or loss
- Evidence of drug abuse
- Regular high alcohol consumption or unwillingness to abstain from alcohol 24 hours before admission and study visits
- Smoking 10 or more cigarettes per day in recent 12 weeks or inability to refrain from smoking 24 hours after dosing
- Any condition or reason making the subject unsuitable or unable to comply with the study protocol
- Confirmed COVID-19 infection at screening or admission
- Vulnerable populations such as study center employees, prisoners, or institutionalized persons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Unidad de Fase I. U. Autonoma de Madrid (Clinical Trials Unit, UAM) C/ Arzobispo Morcillo 4
Madrid, Spain, 28029
Actively Recruiting
Research Team
S
Sohail Biczadehtakori
CONTACT
M
Mandaline Hwee Qi Teo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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