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

NCT05108259 | Recruiting Phase 1

• 1 other identifier: SOLOMON-I
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief Summary

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

Healthy Volunteers

Keywords

randomized; double-blind; phase 1

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)

  Primary endpoints were equivalence of PK between PBP1502 and reference drugs in terms of AUC0-inf. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.

  Up to Day 71

• Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)

  Primary endpoints were equivalence of PK between PBP1502 and reference drugs in terms of AUC0-last. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.

  Up to Day 71

• Maximum Serum Concentration (Cmax)

  Primary endpoints were equivalence of PK between PBP1502 and reference drugs in terms of Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.

  Up to Day 71

Secondary Outcomes (5)

• Time to the Maximum Serum Concentration (Tmax)

  Up to Day 71

• Terminal Elimination Half-life (t1/2)

  Up to Day 71

• Adverse events

  Up to Day 71

• Anti Drug Antibodies (ADAs)

  Up to Day 71

• Neutralizing Antibodies (NAbs)

  Up to Day 71

Study Arms (3)

PBP1502

EXPERIMENTAL

Adalimumab single dose 40 mg (100 mg/mL) by SC injection via pre-filled syringe (PFS)

Drug: PBP1502

EU-licensed Humira

ACTIVE COMPARATOR

Adalimumab single dose 40 mg (100 mg/mL) by SC injection via PFS

Drug: EU-licensed Humira

US-licensed Humira

ACTIVE COMPARATOR

Adalimumab single dose 40 mg (100 mg/mL) by SC injection via PFS

Drug: US-licensed Humira

Interventions

PBP1502 DRUG

40 mg/0.4 mL single SC injection via PFS

Also known as: Adalimumab

PBP1502

EU-licensed Humira DRUG

40 mg/0.4 mL single SC injection via PFS

Also known as: Adalimumab

EU-licensed Humira

US-licensed Humira DRUG

40 mg/0.4 mL single SC injection via PFS

Also known as: Adalimumab

US-licensed Humira

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ECG, and clinical laboratory tests prior to administration of the study drug).
• Subject is informed and able to understand the full nature and purpose of the study, including possible risks and side effects, and is given ample time and opportunity to read and understand this information. Subject has the ability and agrees to cooperate with the Investigator and must sign and date the written informed consent prior to performing any of the screening procedures.
• BMI between 18.0 and 32.0 kg/m2, both inclusive.
• Subject and their partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 5 months after the administration of assigned treatment. A man is of childbearing potential if, in the opinion of the Investigator, he is sexually active. Male and female subjects and their partners who have been surgically sterilised for less than 24 weeks prior to the date of informed consent must agree to use any medically acceptable methods of contraception. Menopausal females must have experienced their last period more than 1 year prior to the date of informed consent to be classified as not of childbearing potential

You may not qualify if:

• Subject has a medical history and/or condition including one or more of the following disease(s):
• History and/or current presence of clinically significant atopy (e.g., allergic asthma, eczematous dermatitis), known or suspected clinically relevant hypersensitivity or allergic reactions to any of the excipients of study drug, other murine and human proteins, or Ig products.
• Known infection with hepatitis B (active or carrier of hepatitis B), hepatitis C, or human immunodeficiency virus (HIV). However, a subject with history of hepatitis B virus is allowed if resolved.
• History of invasive systemic fungal infections (including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis, etc.) or other opportunistic infections judged by the Investigator, including local fungal infections or a history of herpes zoster.
• History of and/or current cardiac (including New York Heart Association class III/IV heart failure), gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic haematological (including pancytopenia, aplastic anaemia, or blood dyscrasia, etc.), metabolic (including diabetes mellitus), or pulmonary disease classed as significant by the Investigator.
• History of any malignancy.
• Systemic or local infection, such as the risk of sepsis and/or known active inflammation within 2 months before screening.
• Severe infections requiring hospitalisation and/or the need for IV antibiotics, within 2 months before screening.
• A sign of ongoing or chronic inflammation process defined as high blood concentration of C-reactive protein (CRP) (\> 1.5 times the upper limit of normal \[ULN\]).
• Subject has inadequate liver function as determined by following results:
• Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 1.5 × ULN and
• Total bilirubin \> 1.5 × ULN.
• Subject is considered to have a significant abnormal cardiac function in Investigator's discretion determined by the laboratory results.
• Subject underwent surgical intervention or an operation within 4 weeks prior to the administration of the study drug (Day 1) or plans to undergo a surgical procedure during the study period.
• Subject has active TB, latent TB (defined as a positive result for IGRA with no active lesion in examination of chest X-ray without any sign or symptom of TB), a history of TB, or had close contact with a person with active TB within 8 weeks prior to the administration of the study drug (Day 1). If the result of IGRA is indeterminate at screening, retest will be allowed only once during the screening period. If the repeated IGRA result is again indeterminate or positive, the subject will be excluded from the study. If the repeated IGRA result is negative, the subject may be included in the study.

Sponsors & Collaborators

• Prestige Biopharma Limited: lead

Study Sites (1)

Unidad de Fase I. U. Autonoma de Madrid (Clinical Trials Unit, UAM) C/ Arzobispo Morcillo 4

Madrid, 28029, Spain

RECRUITING

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Sohail Biczadehtakori

CONTACT

+65-6924-6535; sohail@prestigebio.com

Mandaline Hwee Qi Teo

CONTACT

+65-6924-6535; mandaline.teo@prestigebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: November 4, 2021
• Study Start: March 30, 2022
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)