Healthy VolunteersPhase 1NCT05108259
To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects
A Phase 1 study testing PBP1502 and EU-licensed Humira in people with Healthy Volunteers, run by Prestige Biopharma Limited at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PBP1502 and EU-licensed Humira
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2022to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
- Central nervous system demyelinating disease (e.g., multiple sclerosis and optic neuritis), and peripheral demyelinating disease, (e.g., Guillain-Barré syndrome)
- A sign of ongoing or chronic inflammation process defined as high blood concentration of C-reactive protein (CRP) (> 2.5 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) > 2 × ULN and
- Total bilirubin > 2 × 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.
- Female subject is pregnant or lactating or planning to be pregnant or to breastfeed before, during, or within 5 months after the administration of the study drug (Day 1).
- Male subject is planning to father a child or donate sperms within 5 months after the administration of the study drug (Day 1).
- Subject has received a mAb or fusion protein within 9 months prior to randomization and/or there is a confirmed evidence or clinical suspicion of immunogenicity from previous exposure to a mAb or fusion protein, or subject is currently using a biologic (including but not limited to TNF-α blockers). Subjects with previous exposure to adalimumab are to be excluded.
- Subject has received treatment with a biological or immunosuppressive agent (other than a mAb or fusion protein) within 3 months of screening.
- Subject used prescription (excluding hormonal birth control), over the counter (OTC) drugs, dietary supplements, or herbal remedies that could affect the outcome of the study within 2 weeks prior to the administration of the study drug (Day 1).
- Subject has undergone treatment with an investigational drug or participated in another clinical study for healthy subject or bioequivalence test within 180 days or 5 half-lives (whichever is longer) prior to the administration of the study drug (Day 1) or plan to do so during the study.
- Subject received a live or live-attenuated vaccine within 4 weeks prior to the administration of the study drug (Day 1) or plan to do so until 6 months after Day 1.
- Subject has donated or lost 400 mL or more of whole blood within 8 weeks, or donated blood components within 4 weeks prior to the administration of the study drug (Day 1).
- Subject shows reasonable evidence of drug abuse (positive result for drug urine test and/or the opinion of the Investigator).
- Subject has a history or presence of regular consumption exceeding an average weekly intake of 21 units of alcohol in recent 12 weeks prior to the screening visit. One unit is equivalent to a half-pint (285 mL) of beer/lager, one measure (25 mL) of spirits, or one small glass (125 mL) of wine. Subject is unwilling to avoid use of alcohol or alcohol containing foods, medications, or beverages within 24 hours prior to admission (Day -1), and each study visit until completion of the study.
- Subject has smoked 10 or more cigarettes per day in the recent 12 weeks prior to the administration of the study drug (Day 1) and/or is unable to refrain from smoking up to 24 hours after the administration of the study drug.
- In the opinion of the Investigator, the subject is not eligible for the study participation for any reason (including clinical laboratory results) or shows evidence of a condition (e.g., psychological, or emotional problem, any disorder or resultant therapy) that is likely to invalidate an informed consent or limit the ability of the subject to comply with the protocol requirements. Subject is unable to understand the protocol requirements, instructions, study-related restrictions, or the nature, scope, and possible consequences of the clinical study; or is unable to give written informed consent or to comply fully with the protocol.
- Subject with confirmed COVID-19 infection by appropriate laboratory test screening and on admission.
- Subject is vulnerable (e.g., employees of the study centre or any other individuals involved with the conduct of the study, or immediate family members of such individuals, persons kept in prison, or other institutionalised persons by law enforcement).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad de Fase I. U. Autonoma de Madrid (Clinical Trials Unit, UAM) C/ Arzobispo Morcillo 4
Madrid, 28029
About this study
Official title: A Phase 1, Double-blind, Randomized, Three-arm, Parallel Group Study to Compare the Pharmacokinetics and Safety of a Single Subcutaneous Dose of PBP1502, EU-Humira®, and US-Humira® in Healthy Male and Female 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 volunteers.
Read the detailed description
This is a single centre, randomized, double-blind, three-arm, parallel group, single-dose, active comparator study, where a total of 324 healthy male and female adult volunteers - between the age of 18 and 55 years, both inclusive - will be dosed; 108 subjects per treatment group, randomly assigned to one of the 3 treatment arms.
- Conditions
- Healthy Volunteers
- Being tested
- PBP1502, EU-licensed Humira
- Keywords
- randomized, double-blind, phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBP1502Drug
Also called Adalimumab
40 mg/0.4 mL single SC injection via PFS
EU-licensed HumiraDrug
Also called Adalimumab
40 mg/0.4 mL single SC injection via PFS
| Study group | Role | What they receive |
|---|---|---|
| PBP1502 | Experimental | Adalimumab single dose 40 mg (100 mg/mL) by SC injection via pre-filled syringe (PFS) Receives: Drug: PBP1502 |
| EU-licensed Humira | Active comparator | Adalimumab single dose 40 mg (100 mg/mL) by SC injection via PFS Receives: Drug: EU-licensed Humira |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to Day 71
Secondary outcomes (5)
Time to the Maximum Serum Concentration (Tmax)
The secondary objective was to evaluate the additional PK parameters of Tmax. 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.
Measured: Up to Day 71
Terminal Elimination Half-life (t1/2)
The secondary objective was to evaluate the additional PK parameters of t1/2. 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.
Measured: Up to Day 71
Adverse events
Adverse events will be coded using MedDRA and grouped by system organ class and preferred term and summarised, by treatment group at the time of onset of the AE. The summary tables will present the number and percentage of total subjects and number of events, by system organ class and by preferred term. Injection related reactions will be listed and summarised by reaction using frequency counts and percentage, by treatment group.
Measured: Up to Day 71
Anti Drug Antibodies (ADAs)
Formation of Anti Drug Antibody will be measured through a validated assay.
Measured: Up to Day 71
Neutralizing Antibodies (NAbs)
Formation of neutralizing antibodies measured through a validated system
Measured: Up to Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start30 Mar 2022
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prestige Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108259
- Sponsor's protocol ID
- SOLOMON-I
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2021
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized, Three-arm, Parallel Group Study to Compare the Pharmacokinetics and Safety of a Single Subcutaneous Dose of PBP1502, EU-Humira®, and US-Humira® in Healthy Male and Female Subjects.
- ClinicalTrials.gov ID
- NCT05108259
- Acronym / sponsor ID
- SOLOMON-I
- Conditions
- Healthy Volunteers
- Keywords
- randomized, double-blind, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Prestige Biopharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single centre, randomized, double-blind, three-arm, parallel group, single-dose, active comparator study, where a total of 324 healthy male and female adult volunteers - between the age of 18 and 55 years, both inclusive - will be dosed; 108 subjects per treatment group, randomly assigned to one of the 3 treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBP1502 | Experimental | Drug: PBP1502Adalimumab single dose 40 mg (100 mg/mL) by SC injection via pre-filled syringe (PFS) |
| EU-licensed Humira | Active comparator | Drug: EU-licensed HumiraAdalimumab single dose 40 mg (100 mg/mL) by SC injection via PFS |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (30 listed)
- Subject has a medical history and/or condition including one or more of the following disease(s):
- A sign of ongoing or chronic inflammation process defined as high blood concentration of C-reactive protein (CRP) (> 2.5 times the upper limit of normal [ULN]).
- Subject has inadequate liver function as determined by following results:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBP1502Also: Adalimumab40 mg/0.4 mL single SC injection via PFS | Drug | PBP1502 |
| EU-licensed HumiraAlso: Adalimumab40 mg/0.4 mL single SC injection via PFS | Drug | EU-licensed Humira |
Primary outcome
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
Time frame: Up to Day 71
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.
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
Time frame: Up to Day 71
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.
Maximum Serum Concentration (Cmax)
Time frame: Up to Day 71
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.
5 secondary outcomes
Time to the Maximum Serum Concentration (Tmax)
Time frame: Up to Day 71
Terminal Elimination Half-life (t1/2)
Time frame: Up to Day 71
Adverse events
Time frame: Up to Day 71
Anti Drug Antibodies (ADAs)
Time frame: Up to Day 71
Neutralizing Antibodies (NAbs)
Time frame: Up to Day 71
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PBP1502 and EU-licensed Humira in people with Healthy Volunteers, run by Prestige Biopharma Limited at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (time frame: Up to Day 71). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.