Rheumatoid ArthritisPhase 1NCT07207954
Study of LFD-200 in Healthy Adults and Adults With Moderate to Severe Rheumatoid Arthritis
A Phase 1 study testing LFD-200 and Oral Prednisone in people with Rheumatoid Arthritis, run by Lifordi Immunotherapeutics, Inc. at 10 sites in 5 countries.
Trial summary
This is a double-blind, randomized, placebo- and active-controlled study investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) doses of LFD-200. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- LFD-200 and Oral Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 6 Oct 2025to 16 Jul 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-55
- BMI - 18-32
- Participants must be deemed by the Investigator to be generally healthy individuals based on a medical evaluation that includes a physical examination, medical history, vital signs, and the results from clinical labs and other safety assessments collected during the Screening period.
- Adults of age 18 to 75 years, inclusive, at the time of signing the ICF.
- BMI within the range of 18.0- to 35.0 kg/m² (inclusive).
- Has RA for ≥6 months.
Show all 12Show fewer
- Positive rheumatoid factor (RF) or anti-citrullinated protein antibody (ACPA) test at Screening (low or high positive acceptable).
- A high-sensitivity C-reactive protein (hsCRP) level at Screening must be >ULN.
- Has active RA disease defined as follows:
- Disease Activity Score of 28 joints-CRP (DAS28-CRP) >3.2 at Screening and Baseline
- Has ≥4 swollen and ≥4 tender joints on a 28-joint count at Screening and Baseline
- On MTX orally or subcutaneously for at least 12 weeks prior to Screening. Dose of MTX (including route of administration) must have been stable at 15 to 25 mg weekly (or 10 to15mg in case of documented intolerance) for ≥ 12weeks at Randomization with plans to continue it at the same dose and route of administration for the duration of the study.
Who cannot join
- Participants with any current or previous illness that, in the opinion of the investigator, might confound the results of the study or pose an additional, unacceptable risk to the participant or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation.
- Recent serious or ongoing infection
- Known/suspected primary immunodeficiency
- Receipt of injected or systemic glucocorticoids within 6 weeks prior to screening
- Use of prohibited medications
- Any of the following lab abnormalities:
Show all 52Show fewer
- White blood cell (WBC) count <3.0 x 109/L
- Absolute neutrophil count (ANC) <2.0 x 109/L
- Hemoglobin (Hgb) <12.5 g/dL for males and <11.5 g/dL for females
- Platelet count <140 x 109/L
- Alanine transaminase (ALT) ≥1.2x upper limit of normal (ULN)
- Total bilirubin ≥1.2x ULN (except if Gilbert's disease is suspected etiology)
- Estimated glomerular filtration rate (eGFR) <80 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) formula.
- International normalized ratio (INR) ≥1.2 × ULN
- Glycated hemoglobin (HbA1c) >6%
- Positive urine cotinine test (Day -1 only), alcohol breath test or urine drug screen for substances of abuse. Positive tetrahydrocannabinol (THC) is not exclusionary.
- A Screening thyroid stimulating hormone (TSH) level that is <0.9 × lower limit normal (LLN) or ≥1.2 × ULN
- Cortisol level <1.0 × LLN (Collected in the AM at the Baseline Visit)
- Clinical evidence of significant unstable or uncontrolled acute or chronic diseases (e.g., cardiac [including congestive heart failure, angina, or history of myocardial infarction], pulmonary [including chronic obstructive pulmonary disease, asthma requiring systemic GC therapy, pulmonary hypertension, or pulmonary fibrosis], hematologic, gastrointestinal, hepatic, renal, neurological, psychiatric, dermatologic, musculoskeletal, or infectious diseases) that, in the opinion of the Investigator or Sponsor, constitutes an inappropriate risk or contraindication for participation in study or that could interfere with study objectives, conduct, or evaluation
- Any other autoimmune or autoinflammatory disorder, which in the opinion of Investigator/Sponsor would constitute an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation.
- Recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection
- Known seropositivity for or active infection by HIV or strongyloides (if at risk of exposure (e.g., travel from/reside in endemic area))
- Active or latent TB infection, as suggested by a positive chest radiograph OR positive/indeterminate QFT-TB Gold Plus or T-SPOT within the 12 weeks prior to Screening or a positive Screening CXR or QFT test. Indeterminate screening QFT tests are also exclusionary but may be repeated once and will be considered positive if retest results are positive or indeterminate/borderline.
- Clinically significant abnormalities on ECG per the Investigator or Sponsor or any of the following mean ECG parameters on screening/baseline (triplicate) ECG:
- HR <40 or >100 beats per minute
- QTcF (Fridericia corrected QT) interval >450 ms (males) or >470 ms (females)
- QRS interval >120 ms
- PR interval >220 ms
- Use or anticipated use of medications for the timeframes specified below:
- Unstable use of any herbal medicines (e.g., St. John's wort) and supplements within 4 weeks prior to Screening through Baseline or anticipated changes in use during study.
- Systemic or local (e.g., topical, oral, ophthalmic) corticosteroid (CS) use within 6 weeks prior to randomization or anticipated use during the study (other than as study intervention).
- Any intra-articular injection within 4 weeks prior to Screening through Baseline or anticipated use during the study.
- Use of cyclophosphamide, chlorambucil, leflunomide for <6 months or cyclosporine, mycophenolic acid, azathioprine, tacrolimus, or gold <8 weeks prior to Screening through Baseline or anticipated use during the study.
- Receipt of rituximab or any other cell depleting biologic therapy within 1 year of Screening through Baseline or anticipated use during the study.
- Use of any other commercial injectable biologic (including those for other non- arthritic conditions such as asthma, osteoporosis, lipids, atopic dermatitis) within 12 weeks or 5 half-lives (whichever is longer) prior to Screening through Baseline, or anticipated use during the study.
- Use of any other oral DMARD, including JAK-inhibitors, within 12 weeks prior to Screening through Baseline or anticipated used during the study. MTX or HCQ use is permitted as specified in the Inclusion Criteria
- Use of >1 systemic biologic therapy for the treatment of RA prior to Screening or Baseline. For those participants that have used no more than one systemic biologic therapy, the systemic biologic therapy must have been discontinued at least 12 weeks or 5 half-lives (whichever is longer) prior to Screening with no use through Baseline or anticipated use during the study.
- Receiving or has received any investigational drug (or is currently using an investigational device) within 30 days or 5 half-lives (whichever is longer), prior to Screening.
- Unstable use of topical or systemic nonsteroidal anti-inflammatory drugs (NSAIDs) OR use above the maximum allowed doses OR use of more than 1 systemic NSAID (other than prophylactic aspirin ≤325mg daily) in the 2 weeks prior to Screening through Baseline or anticipated use during the study.
- The presence at Screening of any laboratory values of concern in the opinion of the Investigator or Sponsor or of any of the below based on central laboratory testing at Screening:
- WBC count <3.0 × 10⁹/L
- ANC <2.0 × 10⁹/L
- Hgb <10 g/dL
- Platelet count <100 × 10⁹/L
- ALT >2 × ULN
- Total bilirubin ≥1.5 × ULN (unless Gilbert's disease is suspected)
- eGFR <45 mL/min/1.73m² estimated based on CKD-EPI 2021 formula
- International normalized ratio >1.2 × ULN
- HbA1c >8%
- AM cortisol level at Baseline Visit <0.9 × LLN
- Positive alcohol breath test or urine drug screen for substances of abuse. Positive THC or positivity for other substances due to ongoing use of these drugs under physician supervision (e.g., prescription narcotics for known pain disorder) are not exclusionary.
- A Screening TSH level that is <0.9 × LLN or > 1.1 × ULN.
Trial locations and contacts
10 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 5 countries
Ukraine5 sites, 5 recruiting
- Recruiting
Medical Center of LLC ARENSIA Exploratory Medicine
Ivano-Frankivsk, 76000
- Recruiting
Medical Center Artes Medicum
Kyiv, 02002
- Recruiting
Medical Center 'Ok!Clinic+' of International Institute of Clinical Research
Kyiv, 02091
- Recruiting
"ARENSIA EXPLORATORY MEDICINE" LIMITED LIABILITY COMPANY, Medical Center, Department of Clinical Trials
Kyiv, 1135
- Recruiting
Medical Clinical Investigational Center "Medical Center Health Clinic", LLC
Vinnytsia, 21009
Poland2 sites, 2 recruiting
- Recruiting
MICS Centrum Medyczne Torun - MICS - PPDS
Torun, 87-100
- Recruiting
Centrum Medyczne Reuma Park
Warsaw, 02-691
Georgia1 site, 1 recruiting
- Recruiting
Arensia Exploratory Medicine LLC
Tbilisi, 112
Moldova1 site, 1 recruiting
- Recruiting
Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E.M.
Chisinau, MD2025
About this study
Official title: A Phase 1a/1b, Randomized, Double-Blind, Placebo- and Active-Controlled, Single and Multiple Ascending Dose Study Evaluating the Comparative Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LFD-200 in Adult Participants Who Are Healthy or Have Moderate to Severe Rheumatoid Arthritis
This is a double-blind, randomized, placebo- and active-controlled study investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) doses of LFD-200. The study design includes: a single ascending dose (SAD) study in up to 66 adult healthy participants (HPs) to investigate the effects of a single SC dose, with a 30-day follow-up; a multiple ascending dose (MAD) study in up to 40 HPs to assess up to 4 weekly SC doses, with a 30-day follow-up after the last dose; and a MAD study in up to 70 participants with moderate to severe rheumatoid arthritis (RA) to evaluate up to 13 weekly SC doses, with a 30-day follow-up after the last dose.
- Conditions
- Rheumatoid Arthritis
- Being tested
- LFD-200, Placebo, Oral Prednisone
- Keywords
- RA, Rheumatoid Arthritis, Healthy Participants, Phase 1a/1b, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, First in human, Single Ascending Dose, Multiple Ascending Dose
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFD-200Drug
2 mL glass vials, as 150 mg/mL concentrated solution
PlaceboOther
0.9% NaCl
Oral PrednisoneDrug
Tablet
PlaceboOther
Placebo tablet to match Prednisone
| Study group | Role | What they receive |
|---|---|---|
| Part 1: SAD in HP | Experimental | Three planned cohorts (SAD HP Cohorts 1 to 3) and 3 optional cohorts (SAD HP Cohorts 4 to-6) of 11 participants each will receive a single SC dose of LFD-200, a single SC dose of matching saline placebo, or a single oral dose of open label 10 mg prednisone. Within each cohort, 6 participants will be randomly assigned to receive LFD-200, 2 participants will receive saline placebo, and 3 will receive prednisone. Receives: Drug: LFD-200; Other: Placebo; Drug: Oral Prednisone |
| Part 1: MAD in HP | Experimental | Two planned cohorts (MAD HP Cohorts 1 and 2) of 8 HPs each (16 total) will be randomly assigned to receive 4 weekly SC doses of LFD-200 (6 participants) or saline placebo (2 participants) over a duration of 22 days. Receives: Drug: LFD-200; Other: Placebo |
| Part 2: MAD in RA | Experimental | Two planned cohorts (MAD RA Cohorts 1 and 2) of 14 RA participants each (28 total) will be randomly assigned to receive either up to 13 weekly SC doses of LFD-200 over 85 days with a daily prednisone placebo tablet (LFD-200 arm; 8 participants), or up to 13 weekly SC doses of saline placebo over 85 days with daily prednisone placebo tablet (placebo arm; 3 participants), or up to 13 weekly SC doses of saline placebo over 85 days with a daily dose of oral prednisone (prednisone arm; 3 participants) Receives: Drug: LFD-200; Other: Placebo; Drug: Oral Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Number of participants experiencing any adverse events during the study period.
Measured: Baseline up to 30 days after last dose.
Severity of Adverse Events (AEs)
Classification of adverse events based on severity (mild, moderate, severe).
Measured: Baseline up to 30 days after last dose.
Seriousness of Adverse Events (AEs)
Number of participants experiencing serious adverse events (SAEs) during the study period.
Measured: Baseline up to 30 days after last dose.
Change from Baseline in Blood Pressure (BP)
Difference in systolic and diastolic blood pressure measurements from baseline to specified time points.
Measured: Baseline up to 30 days after last dose.
Change from Baseline in Temperature
Difference in body temperature measurements from baseline to specified time points.
Measured: Baseline up to 30 days after last dose.
Change from Baseline in Respiratory Rate
Difference in respiratory rate measurements from baseline to specified time points.
Measured: Baseline up to 30 days after last dose.
Change from Baseline in Heart Rate (HR)
Difference in heart rate measurements from baseline to specified time points.
Measured: Baseline up to 30 days after last dose.
Change in Hemeglobin from Baseline to specified timepoints
Hemeglobin is measured in g/dL
Measured: Baseline up to 30 days after last dose.
Change in Alanine Aminotransferase from Baseline to specified timepoints
Alanine Aminotransferase is measured in U/L
Measured: Baseline up to 30 days after last dose.
Change in Leukocytes in urine from Baseline to specified timepoints
Leukocytes in urine is measured in x10^6/L
Measured: Baseline up to 30 days after last dose.
Change in Heart Rate (HR) from Baseline to specified timepoints
Heart rate is measured in beats per minute
Measured: Baseline up to 30 days after last dose.
Change from Baseline in PR Interval
Difference in PR interval measurements from baseline to specified time points.
Measured: Baseline up to 30 days after last dose.
Change from Baseline in QRS Interval
Difference in QRS interval measurements from baseline to specified time points.
Measured: Baseline up to 30 days after last dose.
Change from Baseline in QT Interval
Difference in QT interval measurements from baseline to specified time points.
Measured: Baseline up to 30 days after last dose.
Primary Outcome Measure: Change from Baseline in QTcF Interval
Difference in QTcF interval measurements from baseline to specified time points.
Measured: Baseline up to 30 days after last dose.
Incidence of Clinical Findings on Physical Examination
Number of participants with clinical findings during physical examinations, including injection site reactions.
Measured: Baseline up to 30 days after last dose.
Severity of Clinical Findings on Physical Examination
Classification of clinical findings based on severity (mild, moderate, severe), including injection site reactions.
Measured: Baseline up to 30 days after last dose.
Secondary outcomes (14)
Maximum Observed Plasma Concentration (Cmax)
The highest concentration of the drug observed in plasma after administration.
Measured: Baseline up to 30 days after last dose.
Trough Concentration (Ctrough)
The lowest concentration of the drug observed in plasma before the next dose.
Measured: Baseline up to 30 days after last dose.
Average Concentration (Cavg)
The average concentration of the drug in plasma over a specified time period
Measured: Baseline up to 30 days after last dose.
Clearance
The rate at which the drug is removed from the body.
Measured: Baseline up to 30 days after last dose.
Volume of Distribution
The volume in which the drug is distributed in the body.
Measured: Baseline up to 30 days after last dose.
Area Under the Plasma Concentration vs. Time Curve from Time Zero to the Last Quantifiable Concentration (AUClast)
The area under the plasma concentration-time curve from the time of dosing to the last measurable concentration.
Measured: Baseline up to 30 days after last dose.
Area Under the Plasma Concentration vs. Time Curve from Time Zero Extrapolated to Infinity (AUCinf)
The area under the plasma concentration-time curve from the time of dosing extrapolated to infinity.
Measured: Baseline up to 30 days after last dose.
Area Under the Plasma Concentration vs. Time Curve from Time Zero to 168 Hours Post-Dose (AUC0-168)
The area under the plasma concentration-time curve from the time of dosing to 168 hours post-dose.
Measured: Baseline up to 30 days after last dose.
Area Under the Plasma Concentration vs Time Curve Over the Dosing Interval (AUCtau)
The area under the plasma concentration-time curve over the dosing interval.
Measured: Baseline up to 30 days after last dose.
Accumulation Ratio (Rac)
The ratio of drug accumulation in plasma after multiple dosing compared to a single dose.
Measured: Baseline up to 30 days after last dose.
Time Corresponding to the Maximum Observed Plasma Concentration (Tmax)
The time at which the maximum plasma concentration of the drug is observed.
Measured: Baseline up to 30 days after last dose.
Change from Baseline in Cortisol Levels
Difference in cortisol levels from baseline to specified time points.
Measured: Baseline up to 30 days after last dose.
Change from Baseline in Bone Biomarkers
Difference in Bone Biomarker levels from baseline to specified time points
Measured: Baseline up to 30 days after last dose.
Change from Baseline in DAS28-CRP
Difference in Disease Activity Score 28 - C-reactive protein (DAS28-CRP) from baseline to specified time points for rheumatoid arthritis (RA) cohorts.
Measured: Baseline up to 30 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start6 Oct 2025
- Primary completion16 Jul 2027 (estimated)
- Study completion16 Jul 2027 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifordi Immunotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207954
- Sponsor's protocol ID
- LFD200A11
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2025
- Last updated
- 29 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b, Randomized, Double-Blind, Placebo- and Active-Controlled, Single and Multiple Ascending Dose Study Evaluating the Comparative Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LFD-200 in Adult Participants Who Are Healthy or Have Moderate to Severe Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07207954
- Acronym / sponsor ID
- LFD200A11
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA, Rheumatoid Arthritis, Healthy Participants, Phase 1a/1b, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Lifordi Immunotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 16 Jul 2027 (estimated)
- Study completion
- 16 Jul 2027 (estimated)
- First posted
- 6 Oct 2025 (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 double-blind, randomized, placebo- and active-controlled study investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) doses of LFD-200. The study design includes: a single ascending dose (SAD) study in up to 66 adult healthy participants (HPs) to investigate the effects of a single SC dose, with a 30-day follow-up; a multiple ascending dose (MAD) study in up to 40 HPs to assess up to 4 weekly SC doses, with a 30-day follow-up after the last dose; and a MAD study in up to 70 participants with moderate to severe rheumatoid arthritis (RA) to evaluate up to 13 weekly SC doses, with a 30-day follow-up after the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: SAD in HP | Experimental | Drug: LFD-200, Other: Placebo, Drug: Oral PrednisoneThree planned cohorts (SAD HP Cohorts 1 to 3) and 3 optional cohorts (SAD HP Cohorts 4 to-6) of 11 participants each will receive a single SC dose of LFD-200, a single SC dose of matching saline placebo, or a single oral dose of open label 10 mg prednisone. Within each cohort, 6 participants will be randomly assigned to receive LFD-200, 2 participants will receive saline placebo, and 3 will receive prednisone. |
| Part 1: MAD in HP | Experimental | Drug: LFD-200, Other: PlaceboTwo planned cohorts (MAD HP Cohorts 1 and 2) of 8 HPs each (16 total) will be randomly assigned to receive 4 weekly SC doses of LFD-200 (6 participants) or saline placebo (2 participants) over a duration of 22 days. |
| Part 2: MAD in RA | Experimental | Drug: LFD-200, Other: Placebo, Drug: Oral PrednisoneTwo planned cohorts (MAD RA Cohorts 1 and 2) of 14 RA participants each (28 total) will be randomly assigned to receive either up to 13 weekly SC doses of LFD-200 over 85 days with a daily prednisone placebo tablet (LFD-200 arm; 8 participants), or up to 13 weekly SC doses of saline placebo over 85 days with daily prednisone placebo tablet (placebo arm; 3 participants), or up to 13 weekly SC doses of saline placebo over 85 days with a daily dose of oral prednisone (prednisone arm; 3 participants) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-55
- BMI - 18-32
- Participants must be deemed by the Investigator to be generally healthy individuals based on a medical evaluation that includes a physical examination, medical history, vital signs, and the results from clinical labs and other safety assessments collected during the Screening period.
- Adults of age 18 to 75 years, inclusive, at the time of signing the ICF.
- BMI within the range of 18.0- to 35.0 kg/m² (inclusive).
Key exclusion criteria (52 listed)
- Participants with any current or previous illness that, in the opinion of the investigator, might confound the results of the study or pose an additional, unacceptable risk to the participant or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation.
- Recent serious or ongoing infection
- Known/suspected primary immunodeficiency
- Receipt of injected or systemic glucocorticoids within 6 weeks prior to screening
- Use of prohibited medications
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 |
|---|---|---|
| LFD-2002 mL glass vials, as 150 mg/mL concentrated solution | Drug | Part 1: MAD in HP, Part 1: SAD in HP, Part 2: MAD in RA |
| Placebo0.9% NaCl | Other | Part 1: MAD in HP, Part 1: SAD in HP, Part 2: MAD in RA |
| Oral PrednisoneTablet | Drug | Part 1: SAD in HP, Part 2: MAD in RA |
| PlaceboPlacebo tablet to match Prednisone | Other | Part 2: MAD in RA |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Baseline up to 30 days after last dose.
Number of participants experiencing any adverse events during the study period.
Severity of Adverse Events (AEs)
Time frame: Baseline up to 30 days after last dose.
Classification of adverse events based on severity (mild, moderate, severe).
Seriousness of Adverse Events (AEs)
Time frame: Baseline up to 30 days after last dose.
Number of participants experiencing serious adverse events (SAEs) during the study period.
Change from Baseline in Blood Pressure (BP)
Time frame: Baseline up to 30 days after last dose.
Difference in systolic and diastolic blood pressure measurements from baseline to specified time points.
Change from Baseline in Temperature
Time frame: Baseline up to 30 days after last dose.
Difference in body temperature measurements from baseline to specified time points.
Change from Baseline in Respiratory Rate
Time frame: Baseline up to 30 days after last dose.
Difference in respiratory rate measurements from baseline to specified time points.
Change from Baseline in Heart Rate (HR)
Time frame: Baseline up to 30 days after last dose.
Difference in heart rate measurements from baseline to specified time points.
Change in Hemeglobin from Baseline to specified timepoints
Time frame: Baseline up to 30 days after last dose.
Hemeglobin is measured in g/dL
Change in Alanine Aminotransferase from Baseline to specified timepoints
Time frame: Baseline up to 30 days after last dose.
Alanine Aminotransferase is measured in U/L
Change in Leukocytes in urine from Baseline to specified timepoints
Time frame: Baseline up to 30 days after last dose.
Leukocytes in urine is measured in x10^6/L
Change in Heart Rate (HR) from Baseline to specified timepoints
Time frame: Baseline up to 30 days after last dose.
Heart rate is measured in beats per minute
Change from Baseline in PR Interval
Time frame: Baseline up to 30 days after last dose.
Difference in PR interval measurements from baseline to specified time points.
Change from Baseline in QRS Interval
Time frame: Baseline up to 30 days after last dose.
Difference in QRS interval measurements from baseline to specified time points.
Change from Baseline in QT Interval
Time frame: Baseline up to 30 days after last dose.
Difference in QT interval measurements from baseline to specified time points.
Primary Outcome Measure: Change from Baseline in QTcF Interval
Time frame: Baseline up to 30 days after last dose.
Difference in QTcF interval measurements from baseline to specified time points.
Incidence of Clinical Findings on Physical Examination
Time frame: Baseline up to 30 days after last dose.
Number of participants with clinical findings during physical examinations, including injection site reactions.
Severity of Clinical Findings on Physical Examination
Time frame: Baseline up to 30 days after last dose.
Classification of clinical findings based on severity (mild, moderate, severe), including injection site reactions.
14 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Baseline up to 30 days after last dose.
Trough Concentration (Ctrough)
Time frame: Baseline up to 30 days after last dose.
Average Concentration (Cavg)
Time frame: Baseline up to 30 days after last dose.
Clearance
Time frame: Baseline up to 30 days after last dose.
Volume of Distribution
Time frame: Baseline up to 30 days after last dose.
Area Under the Plasma Concentration vs. Time Curve from Time Zero to the Last Quantifiable Concentration (AUClast)
Time frame: Baseline up to 30 days after last dose.
Area Under the Plasma Concentration vs. Time Curve from Time Zero Extrapolated to Infinity (AUCinf)
Time frame: Baseline up to 30 days after last dose.
Area Under the Plasma Concentration vs. Time Curve from Time Zero to 168 Hours Post-Dose (AUC0-168)
Time frame: Baseline up to 30 days after last dose.
Area Under the Plasma Concentration vs Time Curve Over the Dosing Interval (AUCtau)
Time frame: Baseline up to 30 days after last dose.
Accumulation Ratio (Rac)
Time frame: Baseline up to 30 days after last dose.
Time Corresponding to the Maximum Observed Plasma Concentration (Tmax)
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in Cortisol Levels
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in Bone Biomarkers
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in DAS28-CRP
Time frame: Baseline up to 30 days after last dose.
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 29 Sep 2026.
- Individual participant dataSharing planned: No
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A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LFD-200 and Oral Prednisone in people with Rheumatoid Arthritis, run by Lifordi Immunotherapeutics, Inc. at 10 sites in 5 countries.
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 12 inclusion and 52 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: looking for participants now, as of the sponsor's last update on 29 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 10 sites in Ukraine, Poland, Australia, Georgia, Moldova. 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?
Contact Matthew McClure, MD (+14158107700, mmcclure@lifordi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: Baseline up to 30 days after last dose.). The study lists 17 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 29 Sep 2026.