To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects

Recruiting Phase 1 Interventional Study
Healthy Volunteers
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
324 (estimated)
Sponsor
Prestige Biopharma Limited · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Healthy male or female subjects, between the age of 18 and 55 years, both inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead EC…
Contacts

Sohail Biczadehtakori

+65-6924-6535

sohail@prestigebio.com

CONTACT

Mandaline Hwee Qi Teo

+65-6924-6535

mandaline.teo@prestigebio.com

CONTACT