Rheumatoid ArthritisPhase 1FolSmartNCT05117593
Investigate the Safety, Tolerability and Pharmacokinetics of FBL-MTX
A Phase 1 study testing FBL-MTX in people with Rheumatoid Arthritis, run by SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd at 1 site in Portugal.
Trial summary
This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study to evaluate the safety, tolerability and pharmacokinetics of FBL-MTX in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- FBL-MTX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 sitePortugal
- Study dates
- 28 Jun 2021to 19 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Signed informed consent prior to any study-mandated procedure.
- Healthy male or female subjects aged between 18 and 55 years (inclusive) at Screening.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- Ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the study requirements.
- Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured on the same arm after ≥5 min in the supine position, at Screening and on Day -1.
- Estimated glomerular filtration rate calculated using the Cockcroft-Gault equation ≥ 90 mL/min at Screening.
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- A female subject of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1 and must agree to consistently and correctly use (from Screening, during the entire study, and for at least 6 months after investigational product administration) a highly effective method of contraception with a failure rate of ≤1% per year, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must be initiated at least 1 month before the treatment administration.
- A female subject of non-childbearing potential, must be post-menopausal (defined as 12 consecutive months with no menses without an alternative medical cause, confirmed by a follicle stimulating hormone [FSH] test), or must have a medical history of previous bilateral salpingectomy, bilateral salpingo-oophorectomy, hysterectomy, premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, or uterine agenesis.
- A male subject must use adequate contraception (e.g., condom) from investigational product administration up to at least 6 months after, unless he is vasectomized or sexually inactive. In addition, the subject must ensure that his female partner of childbearing potential agrees to consistently and correctly use for the same period a highly effective method of contraception with a failure rate of ≤1% per year.
- A male subject must agree to refrain from donation of semen from investigational product administration up to at least 6 months after.
Who cannot join
- Previous exposure to FBL-MTX.
- Known hypersensitivity to MTX or any other FBL-MTX components.
- Clinically relevant findings on physical examination at Screening or on Day -1.
- Clinically relevant abnormalities on 12-lead ECG, measured after 5 min in a supine position, at Screening or on Day -1.
- Clinically relevant abnormalities on chest X-ray at Screening.
- Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis) at Screening or on Day -1.
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- Pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anemia.
- QTc > 450ms in male and > 470ms in female.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above the normal range.
- Any medical condition, acute, ongoing, recurrent or chronic, that presents a potential risk to the participant and/or that may compromise the objectives of the study.
- History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the distribution, metabolism, or excretion of the investigational product.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator.
- History of tuberculosis.
- Presence of chronic or acute bacterial or viral infection.
- History or presence of an autoimmune disorder.
- History of known or suspected immunodeficiency syndrome
- Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease.
- Any significant acute or chronic medical illness, including past or present liver disease.
- Previous clinically relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access, or puncture, veins with a tendency to rupture during or after puncture).
- Participation in a clinical study involving investigational product administration within 3 months prior to Screening or in more than 2 clinical studies within 1 year prior to Screening.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
- Excessive methylxanthines consumption, defined as ≥ 500 mg per day, at Screening.
- Nicotine intake (e.g., smoking, nicotine patch, nicotine chewing gum, or electronic cigarettes) within 3 months prior to Screening and inability to refrain from nicotine intake from Screening up to End-of-Study (EOS).
- Previous treatment with any prescribed medications or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to investigational product administration.
- Previous treatment with vaccines within 4 weeks prior to investigational product administration.
- Loss of 250 mL or more of blood within 3 months prior to Screening.
- Positive results from urine drug and alcohol screen at Screening or on Day -1.
- Positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and/or HCV antibodies at Screening.
- Positive HIV serology results at Screening.
- Pregnant or lactating woman.
- Any other circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single-Ascending Doses of FBL-MTX in Healthy Subjects
This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study to evaluate the safety, tolerability and pharmacokinetics of FBL-MTX in healthy male and female subjects.
Read the detailed description
The product FBL-MTX consists of Methotrexate (MTX) encapsulating liposomes functionalized with a folate peptide (SP-DS3), which targets activated macrophages of rheumatoid arthritis (RA).
This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study in healthy subjects.
This study is planned to investigate up to 4 dose levels of FBL-MTX. Each dose level will consist of 8 healthy male and female subjects (ratio 1:1, male:female) to have 6 subjects being administered FBL-MTX and 2 subjects being administered placebo (ratio 3:1, active:placebo).
The study is designed to meet the following objectives:
- Primary: To evaluate the safety and tolerability of FBL-MTX following single-ascending intravenous doses to healthy male and female subjects.
- Secondary: To investigate the PK of FBL-MTX following single-ascending intravenous doses to healthy male and female subjects.
- Conditions
- Rheumatoid Arthritis
- Being tested
- FBL-MTX, Placebo
- Keywords
- rheumatoid arthritis, healthy
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBL-MTXDrug
FBL-MTX is available as sterile liposomal dispersion for injection at nominal dose strength of 1 mg/mL of methotrexate free base. The dose of 0.1 mg was selected as starting dose in the present study. Three subsequent FBL-MTX dose levels are pre-planned: 0.33 mg, 1 mg and 2.5 mg.
PlaceboDrug
Placebo will consist of sterile saline 0.9% NaCl solution.
| Study group | Role | What they receive |
|---|---|---|
| FBL-MTX | Experimental | A single dose of FBL-MTX will be administered by slow intravenous injection in the morning, under fasted conditions.
A maximum of 4 dose levels (0.1 mg, 0.33 mg, 1 mg and 2.5 mg) are pre-planned. Receives: Drug: FBL-MTX |
| Placebo | Placebo comparator | A single dose of placebo will be administered by slow injection in the morning, under fasted conditions. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at each time point of measurement in systolic blood pressure
Measurements must be recorded from the subject in the supine position after having rested for at least 5 min
Measured: From study treatment administration up to end of study, an average of 1month
Change from baseline at each time point of measurement in diastolic blood pressure
Measurements must be recorded from the subject in the supine position after having rested for at least 5 min
Measured: From study treatment administration up to end of study, an average of 1month
Change from baseline at each time point of measurement in pulse rate
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in hemoglobin
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in red cell count
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in hematocrit
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in mean corpuscular volume
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in mean corpuscular hemoglobin
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in mean corpuscular hemoglobin concentration
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in red cell distribution width
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in white cell count with differential
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in platelet count
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in mean platelet volume
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in AST
Measurement of aspartate aminotransferase
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in clinical ALT
Measurement of alanine aminotransferase
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in gamma-glutamyltransferase (GGT)
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in alkaline phosphatase (ALP)
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in total bilirubin
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in indirect bilirubin
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in direct bilirubin
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in lactate dehydrogenase (LDH)
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in creatinine
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in urea
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in urate
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in glucose
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in cholesterol
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in triglycerides
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in sodium
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in potassium
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in chloride
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in calcium
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in protein
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in albumin
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in creatine kinase (CK)
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in creatinine clearance
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in glucose in urine
Urinalysis test
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in bilirubin in urine
Urinalysis test
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in ketone in urine
Urinalysis test
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in specific gravity
Urinalysis test
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in hemoglobin in urine
Urinalysis test
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in pH in urine
Urinalysis test
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in protein in urine
Urinalysis test
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in urobilinogen
Urinalysis test
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in nitrite in urine
Urinalysis test
Measured: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in heart rate
Measured: From study treatment administration up to the end of study, an average of 1 month
Change from baseline at each time point of measurement in QT interval corrected with Bazett's formula
Measured: From study treatment administration up to the end of study, an average of 1 month
Change from baseline at each time point of measurement in QT interval corrected with Fridericia's formula (QTcF)
Measured: From study treatment administration up to the end of study, an average of 1 month
Treatment-emergent AEs
Measured: From study treatment administration up to the end of study, an average of 1 month
Treatment-emergent SAEs
Measured: From study treatment administration up to the end of study, an average of 1 month
Treatment-emergent AEs leading to premature study discontinuation.
Measured: From study treatment administration up to the end of study, an average of 1 month
Secondary outcomes (8)
Maximum plasma concentration (Cmax)
Measured: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Time to reach Cmax (tmax).
If the maximum value occurs at more than one timepoint, tmax is defined as the first time point with this value
Measured: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Area under the concentration-time curve (AUC) from time zero to last measurable plasma concentration (AUC0-t)
Calculated using the linear trapezoidal rule.
Measured: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
AUC from time zero to infinity (AUC0-∞)
Calculated as follows: AUC0-∞ = AUC0-t + Ct/λz, where Ct is the last quantifiable concentration at time t and λz is the apparent terminal elimination rate constant.
Measured: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Terminal elimination rate constant (λz).
Measured: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Terminal elimination half-life (t1/2).
Measured: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Apparent plasma clearance (CL/F).
Calculated as Dose / AUC0-∞.
Measured: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Apparent volume of distribution (Vz/F) during the terminal elimination phase
Calculated as Dose / (AUC0-∞ . λz).
Measured: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start28 Jun 2021
- Primary completion19 Oct 2021
- Study completion19 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A maximum of 4 dose levels (0.1 mg, 0.33 mg, 1 mg and 2.5 mg) is preplanned to be investigated in separate sequential cohorts. Each cohort will consist of 8 healthy male and female subjects (3 subjects of either sex on FBL-MTX, 1 of either sex on placebo).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117593
- Sponsor's protocol ID
- FBL-MTX-101
- Acronym
- FolSmart
- Status last verified
- Nov 2021
- First submitted
- 23 Sep 2021
- Last updated
- 22 Nov 2021
- 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 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single-Ascending Doses of FBL-MTX in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05117593
- Acronym / sponsor ID
- FolSmart / FBL-MTX-101
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- SOLFARCOS - Pharmaceutical and Cosmetic Solutions LtdUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 11 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.
This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study to evaluate the safety, tolerability and pharmacokinetics of FBL-MTX in healthy male and female subjects.
Detailed description
The product FBL-MTX consists of Methotrexate (MTX) encapsulating liposomes functionalized with a folate peptide (SP-DS3), which targets activated macrophages of rheumatoid arthritis (RA).
This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study in healthy subjects.
This study is planned to investigate up to 4 dose levels of FBL-MTX. Each dose level will consist of 8 healthy male and female subjects (ratio 1:1, male:female) to have 6 subjects being administered FBL-MTX and 2 subjects being administered placebo (ratio 3:1, active:placebo).
The study is designed to meet the following objectives:
- Primary: To evaluate the safety and tolerability of FBL-MTX following single-ascending intravenous doses to healthy male and female subjects.
- Secondary: To investigate the PK of FBL-MTX following single-ascending intravenous doses to healthy male and female subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A maximum of 4 dose levels (0.1 mg, 0.33 mg, 1 mg and 2.5 mg) is preplanned to be investigated in separate sequential cohorts. Each cohort will consist of 8 healthy male and female subjects (3 subjects of either sex on FBL-MTX, 1 of either sex on placebo).
| Arm | Type | Receives |
|---|---|---|
| FBL-MTX | Experimental | Drug: FBL-MTXA single dose of FBL-MTX will be administered by slow intravenous injection in the morning, under fasted conditions. A maximum of 4 dose levels (0.1 mg, 0.33 mg, 1 mg and 2.5 mg) are pre-planned. |
| Placebo | Placebo comparator | Drug: PlaceboA single dose of placebo will be administered by slow injection in the morning, under fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Signed informed consent prior to any study-mandated procedure.
- Healthy male or female subjects aged between 18 and 55 years (inclusive) at Screening.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- Ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the study requirements.
- Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured on the same arm after ≥5 min in the supine position, at Screening and on Day -1.
Key exclusion criteria (32 listed)
- Previous exposure to FBL-MTX.
- Known hypersensitivity to MTX or any other FBL-MTX components.
- Clinically relevant findings on physical examination at Screening or on Day -1.
- Clinically relevant abnormalities on 12-lead ECG, measured after 5 min in a supine position, at Screening or on Day -1.
- Clinically relevant abnormalities on chest X-ray at Screening.
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 |
|---|---|---|
| FBL-MTXFBL-MTX is available as sterile liposomal dispersion for injection at nominal dose strength of 1 mg/mL of methotrexate free base. The dose of 0.1 mg was selected as starting dose in the present study. Three subsequent FBL-MTX dose levels are pre-planned: 0.33 mg, 1 mg and 2.5 mg. | Drug | FBL-MTX |
| PlaceboPlacebo will consist of sterile saline 0.9% NaCl solution. | Drug | Placebo |
Primary outcome
Change from baseline at each time point of measurement in systolic blood pressure
Time frame: From study treatment administration up to end of study, an average of 1month
Measurements must be recorded from the subject in the supine position after having rested for at least 5 min
Change from baseline at each time point of measurement in diastolic blood pressure
Time frame: From study treatment administration up to end of study, an average of 1month
Measurements must be recorded from the subject in the supine position after having rested for at least 5 min
Change from baseline at each time point of measurement in pulse rate
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in hemoglobin
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in red cell count
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in hematocrit
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in mean corpuscular volume
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in mean corpuscular hemoglobin
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in mean corpuscular hemoglobin concentration
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in red cell distribution width
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in white cell count with differential
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in platelet count
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in mean platelet volume
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in AST
Time frame: From study treatment administration up to end of study, an average of 1 month
Measurement of aspartate aminotransferase
Change from baseline at each time point of measurement in clinical ALT
Time frame: From study treatment administration up to end of study, an average of 1 month
Measurement of alanine aminotransferase
Change from baseline at each time point of measurement in gamma-glutamyltransferase (GGT)
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in alkaline phosphatase (ALP)
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in total bilirubin
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in indirect bilirubin
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in direct bilirubin
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in lactate dehydrogenase (LDH)
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in creatinine
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in urea
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in urate
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in glucose
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in cholesterol
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in triglycerides
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in sodium
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in potassium
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in chloride
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in calcium
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in protein
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in albumin
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in creatine kinase (CK)
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in creatinine clearance
Time frame: From study treatment administration up to end of study, an average of 1 month
Change from baseline at each time point of measurement in glucose in urine
Time frame: From study treatment administration up to end of study, an average of 1 month
Urinalysis test
Change from baseline at each time point of measurement in bilirubin in urine
Time frame: From study treatment administration up to end of study, an average of 1 month
Urinalysis test
Change from baseline at each time point of measurement in ketone in urine
Time frame: From study treatment administration up to end of study, an average of 1 month
Urinalysis test
Change from baseline at each time point of measurement in specific gravity
Time frame: From study treatment administration up to end of study, an average of 1 month
Urinalysis test
Change from baseline at each time point of measurement in hemoglobin in urine
Time frame: From study treatment administration up to end of study, an average of 1 month
Urinalysis test
Change from baseline at each time point of measurement in pH in urine
Time frame: From study treatment administration up to end of study, an average of 1 month
Urinalysis test
Change from baseline at each time point of measurement in protein in urine
Time frame: From study treatment administration up to end of study, an average of 1 month
Urinalysis test
Change from baseline at each time point of measurement in urobilinogen
Time frame: From study treatment administration up to end of study, an average of 1 month
Urinalysis test
Change from baseline at each time point of measurement in nitrite in urine
Time frame: From study treatment administration up to end of study, an average of 1 month
Urinalysis test
Change from baseline at each time point of measurement in heart rate
Time frame: From study treatment administration up to the end of study, an average of 1 month
Change from baseline at each time point of measurement in QT interval corrected with Bazett's formula
Time frame: From study treatment administration up to the end of study, an average of 1 month
Change from baseline at each time point of measurement in QT interval corrected with Fridericia's formula (QTcF)
Time frame: From study treatment administration up to the end of study, an average of 1 month
Treatment-emergent AEs
Time frame: From study treatment administration up to the end of study, an average of 1 month
Treatment-emergent SAEs
Time frame: From study treatment administration up to the end of study, an average of 1 month
Treatment-emergent AEs leading to premature study discontinuation.
Time frame: From study treatment administration up to the end of study, an average of 1 month
8 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Time to reach Cmax (tmax).
Time frame: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Area under the concentration-time curve (AUC) from time zero to last measurable plasma concentration (AUC0-t)
Time frame: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
AUC from time zero to infinity (AUC0-∞)
Time frame: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Terminal elimination rate constant (λz).
Time frame: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Terminal elimination half-life (t1/2).
Time frame: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Apparent plasma clearance (CL/F).
Time frame: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Apparent volume of distribution (Vz/F) during the terminal elimination phase
Time frame: Multiple pharmacokinetic sampling at predefined timepoints from Day 1 (pre-dose) up to Day 7.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No
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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 FBL-MTX in people with Rheumatoid Arthritis, run by SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd at 1 site in Portugal.
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 10 inclusion and 32 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: finished, as of the sponsor's last update on 22 Nov 2021. 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 Portugal. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline at each time point of measurement in systolic blood pressure (time frame: From study treatment administration up to end of study, an average of 1month). The study lists 50 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 22 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.