Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis

An Open-label, Multicenter Study of the Pharmacokinetics, Efficacy and Safety of Olokizumab in Pediatric and Adolescent Patients With Active Juvenile Idiopathic Arthritis

The primary objective of this study is to evaluate the pharmacokinetics (PK) of olokizumab (OKZ) in patients with polyarticular juvenile idiopathic arthritis aged >2 and <18 years in two doses (64 mg or 48 mg every 4 weeks) depending on patient's weight. Secondary objectives are to evaluate the pharmacodynamic (PD) profile, the long-term efficacy and safety of olokizumab in patients with polyarticular juvenile idiopathic arthritis aged >2 and <18 years.

Study Overview

• Status: Recruiting
• Conditions: Juvenile Idiopathic Arthritis
• Intervention / Treatment: Drug: OKZ q4w; Drug: OKZ q4w

Detailed Description

This study is a multicenter, open-label, non-randomized, uncontrolled study with an interim analysis of endpoints after 12 weeks of therapy, a final analysis of endpoints after 24 weeks of therapy, and an additional analysis at the end of all study visits.

The total number of study subjects screened is 71 subjects. Up to 50 patients will begin treatment.

This study includes:

1. A screening period of up to 2 weeks
2. A main period of open label treatment from Week 0 to Week 24 (24 weeks)
3. A period of extended open label treatment from Week 24 to Week 164 (140 weeks)
4. Safety follow-up period from Week 165 to Week 186 (22 weeks)

The total study duration for patients is approximately 188 weeks (including the screening period).

• Study Type: Interventional
• Enrollment (Estimated): 71
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Anna Karpenko; Phone Number: 1552 +7 (495) 956-79-37; Email: karpenko@rpharm.ru
• Study Contact Backup: Name: Darya Bukhanova; Phone Number: +7 (495) 956-79-37; Email: bukhanova@rpharm.ru

Study Locations

• Russia
  • Kazan', Russia, 420012
    • Recruiting
    • Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation
  • Moscow, Russia, 115522
    • Recruiting
    • Federal State Budgetary Scientific Institution "V.A. Nasonova Research Institute of Rheumatology"
  • Moscow, Russia, 119049
    • Recruiting
    • State Budgetary Institution of Healthcare of the City of Moscow "Morozovskaya Children's City Clinical Hospital of the Moscow City Health Department" (GBUZ "Morozovskaya DGBK DZM")
  • Moscow, Russia, 119435
    • Recruiting
    • Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation (Sechenov University)
  • Moscow, Russia, 119991
    • Recruiting
    • Federal State Autonomous Institution "National Medical Research Center for Children's Health" of the Ministry of Health of the Russian Federation
  • Novosibirsk, Russia, 630099
    • Recruiting
    • Limited Liability Company "Healthy Family Medical Center"
  • Rostov-on-Don, Russia, 344022
    • Recruiting
    • Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation
  • Saint Petersburg, Russia, 192148
    • Recruiting
    • LLC "Medical Technologies"
  • Saratov, Russia, 410054
    • Recruiting
    • Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of the Russian Federation
  • Stavropol, Russia, 55000
    • Recruiting
    • Limited Liability Company "Scientific Medical Center of General Therapy and Pharmacology" (LLC "TERAPHARM")
  • Tolyatti, Russia, 445039
    • Recruiting
    • State Budgetary Healthcare Institution of the Samara Region "Tolyatti City Clinical Hospital No. 5"
  • Ufa, Russia, 450083
    • Recruiting
    • Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
  • Voronezh, Russia, 394036
    • Recruiting
    • Federal State Budgetary Educational Institution of Higher Education "Voronezh State Medical University named after N.N. Burdenko" of the Ministry of Health of the Russian Federation
  • Yaroslavl, Russia, 150000
    • Recruiting
    • State Budgetary Institution of Healthcare of the Yaroslavl Region "Regional Children's Clinical Hospital"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Study informed consent form voluntarily and independently signed by patient legal representative
2. Study assent form voluntarily and independently signed by minor study subject (patient)
3. Male or female patients aged ≥12 and <18 years (cohort 1 - subgroup A) or >2 and <12 years (cohort 1 - subgroup B) or >2 and <18 years (cohort 2) at the time of screening initiation and on Day 0
4. Body weight at the start of screening and on Day 0 ≥45 kg (cohort 1 - subgroup A) or ≥30 and <45 kg (cohort 1 - subgroup B) or ≥18 and <30 kg (cohort 2)

5. A reliable diagnosis of juvenile idiopathic arthritis (JIA) according to the JIA International League of Associations for Rheumatology (ILAR) 1 criteria with onset before the age of 16 years:

   1. Seropositive or seronegative polyarthritis (pJIA) ≥3 months before screening, or
   2. Systemic JIA (sJIA) for ≥3 months before screening, provided that joint symptoms persist without active systemic manifestations for ≥3 months before screening, or
   3. Extended oligoarticular JIA (оJIA) ≥3 months before screening
6. American College of Radiology (ACR) criteria of active polyarthritis are met: 5 or more active joints at screening and on Day 0
7. C-reactive protein (CRP) level on screening or in anamnesis, not associated with alternative causes of increase other than the activity of the underlying disease, ≥6 mg/l
8. Intolerance or failure of methotrexate in the dose of ≥15 mg/m^2/week (or less, in a case of documented intolerance of higher doses) for ≥3 months in medical history

Exclusion Criteria:

1. Prior use of any drug that acts directly on IL-6 or IL-6R
2. If methotrexate is administered - any change in dose or in a formulation within 6 weeks prior to Day 0
3. Previous therapy with marketed or experimental conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or biologic disease-modifying anti-rheumatic drugs (bDMARDs) within less than 5 elimination half-lives
4. Use of oral steroids in the doses above 0.2 mg/kg or 10 mg/day of prednisolone daily, whatever is lower, or a change in dose within 2 weeks prior to Day 0, or use of parenteral or topical steroids within 4 weeks prior to Day 0
5. Change in dose of a non-steroidal anti-inflammatory drug (NSAID) within ≤2 weeks prior to Day 0
6. Vaccination with live vaccines within 6 weeks before baseline, or planned vaccination with live vaccines during the study and/or within 6 weeks after the last olokizumab administration
7. Active uveitis at screening or uveitis exacerbation within 24 weeks before screening
8. Laboratory abnormalities (creatinine ≥1 mg/dL (88 mM) for children aged 12 or ≥1.2 mg/dL (106 mM) for children aged 13 and older; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 х upper limit normal (ULN); platelets <180,000/mm^3; white blood count (WBC) <4000/mm^3; neutrophils <2000/mm^3; hemoglobin ≤80 g/L
9. Exclusion criteria related to past or current infection other than tuberculosis
10. Suspected or confirmed current tuberculosis (TB) infection, history of an active or latent TB infection
11. Active course of a disease associated with formation of intestinal diverticula, or any other symptomatic gastrointestinal disease that may increase risk of perforation; or a history of diverticulitis or perforation; or concurrent Crohn's disease or ulcerative colitis
12. Concurrent heart failure New York Heart Association (NYHA) III or IV functional class
13. In patients with diabetes mellitus - HbA1c > 7% within the last 3 months (non-controlled diabetes mellitus)
14. Patients with Steinbrocker class IV functional impairment
15. Presence of systemic autoimmune or autoinflammatory disease, except JIA, or chronic autoimmune hepatitis or diseases of the primary immunodeficiencies group
16. Patients with history of macrophage activation syndrome episodes
17. Exclusion criteria related to concurrent diseases and conditions that may increase potential risk related to participation in the study and study drug exposure
18. Known hypersensitivity to any component of the study drug
19. Pregnant or breast-feeding female participants or planned pregnancy
20. Other protocol-defined non-inclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: OKZ 64 mg q4w; SC injections q4w-Cohort 1	Drug: OKZ q4w; Subcutaneous (SC) injections of OKZ every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection; Other Names: Artlegia; Drug: OKZ q4w; SC injections of OKZ 48 mg every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection; Other Names: Artlegia
Experimental: Arm 2: OKZ 48 mg q4w; SC injections q4w-Cohort 2	Drug: OKZ q4w; Subcutaneous (SC) injections of OKZ every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection; Other Names: Artlegia; Drug: OKZ q4w; SC injections of OKZ 48 mg every 4 weeks; Olokizumab is a sterile solution for subcutaneous injection; Other Names: Artlegia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Olokizumab Cmax (W24) (maximum concentration) over 24 weeks	The Cmax is defined as maximum serum concentration of olokizumab	24 weeks
Olokizumab area under the concentration-time curve (AUC0-W24) over 24 weeks	The AUC0-W24 is defined as area under the plasma concentration-time curve over the dosing interval (AUC0-W24)	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimum drug concentration at steady state (Ctrough,ss)	The Ctrough is defined as concentration observed before treatment administration during repeated dosing at steady state	24 weeks
Maximum concentration (Cmax) of olokizumab after the first administration	The Cmax is defined as maximum serum concentration of olokizumab	4 weeks
Time to reach maximum concentration (tmax) of olokizumab after the first administration	T(max) is defined as the time it takes for a drug to reach the maximum concentration (Cmax) after administration of olokizumab	4 weeks
The area under the concentration-time curve (AUCtau) of olokizumab over the study period	The AUCtau is defined as area under the plasma concentration-time curve over the dosing interval (AUC0-tau)	12, 24, 72 weeks
Concentration before the next dose of olokizumab (Ctrough)	The Ctrough is defined as concentration observed before the next dose of olokizumab during repeated dosing	12, 24, 72 weeks
Time to steady state (tss)	Time to reach steady state will be assessed both graphically and statistically. The statistical approach will involve fitting a repeated measures linear mixed model to natural log-transformed data, using Helmert contrasts to compare earlier and later weeks, and identifying the earliest week where the mean concentration difference is not statistically significant	12, 24, 72 weeks
Area under the concentration-time curve in the steady state (AUCss)	The АUCss is defined as the area under the curve of the plasma concentration of the drug in the dosing interval at steady state	24, 72 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response, based on Juvenile idiopathic Arthritis American College of Rheumatology (JIA ACR) 30, 50, 70 and 90 criteria over the study period	JIA ACR 30 responder is defined as a participant with at least 3 out of the 6 JIA core set variables with ≥ 30% improvement from baseline with no more than 1 of the remaining variables worsened by ≥ 30%; JIA ACR 50 responder is defined as a participant with at least 3 out of the 6 JIA core set variables with ≥ 50% improvement from baseline with no more than 1 of the remaining variables worsened by ≥ 30%; JIA ACR 70 responder is defined as a participant with at least 3 out of the 6 JIA core set variables with ≥ 70% improvement from baseline with no more than 1 of the remaining variables worsened by ≥ 30%; JIA ACR 90 responder is defined as a participant with at least 3 out of the 6 JIA core set variables with ≥ 90% improvement from baseline with no more than 1 of the remaining variables worsened by ≥ 30%	24, 72, 164 weeks
Changes in Juvenile Arthritis Disease Activity Score-10 (JADAS-10) over the study period	The JADAS-10 includes 4 measures: physician global assessment of disease activity (VAS range: 0 to 10; where 0= no activity and 10= maximum activity); parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and 10= maximum activity); count of active joints (range: 0 to 10; where 0= no activity and 10= maximum activity); index of inflammation determined by high-sensitivity C-reactive protein (hs-CRP) or erythrocyte sedimentation rate (ESR) (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity)	24, 72, 164 weeks
Changes in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) over the study period	The JADAS-27 includes 4 measures: physician global assessment of disease activity (VAS range: 0 to 10; where 0= no activity and 10= maximum activity); parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and 10= maximum activity); count of active joints (range: 0 to 27; where 0= no activity and 27= maximum activity); index of inflammation determined by high-sensitivity C-reactive protein (hs-CRP) or erythrocyte sedimentation rate (ESR) (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity)	24, 72, 164 weeks
Changes in Juvenile Arthritis Disease Activity Score-71 (JADAS-71) over the study period	The JADAS-71 includes 4 measures: physician global assessment of disease activity (VAS range: 0 to 10; where 0= no activity and 10= maximum activity); parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and 10= maximum activity); count of active joints (range: 0 to 71; where 0= no activity and 71= maximum activity); index of inflammation determined by high-sensitivity C-reactive protein (hs-CRP) or erythrocyte sedimentation rate (ESR) (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity)	24, 72, 164 weeks
Proportion of patients with minimal disease activity/inactive disease according to Juvenile Arthritis Disease Activity Score (JADAS) criteria	JADAS inactive disease is defined by a JADAS-27 score less than or equal to 1 The JADAS-27 includes 4 measures: physician global assessment of disease activity (VAS range: 0 to 10; where 0= no activity and 10= maximum activity); parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and 10= maximum activity); count of active joints (range: 0 to 27; where 0= no activity and 27= maximum activity); index of inflammation determined by high-sensitivity C-reactive protein (hs-CRP) or erythrocyte sedimentation rate (ESR) (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity)	24, 72, 164 weeks
Changes in physician assessments of disease activity (VAS) over the study period	Physician global assessment of disease activity (VAS range: 0 to 10; where 0= no activity and 10= maximum activity). Higher scores indicate better outcome	24, 72,164 weeks
Changes in patient/parent assessments of disease activity (VAS) over the study period	Parent/patient global assessment of well-being (VAS range: 0 to 10; where 0= no activity and 10= maximum activity). Higher scores indicate better outcome	24, 72, 164 weeks
Changes in the number of active joints over the study period	Active joint is defined as defined as a swollen joint or, in the absence of swelling, with limited mobility accompanied by pain/tenderness	24, 72, 164 weeks
Changes in the number of joints with functional limitations over the study period	Functional limitations is defined as defined as a swollen joint or, in the absence of swelling, with limited mobility accompanied by pain/tenderness	24, 72, 164 weeks
Changes in the Childhood Health Assessment Questionnaire (CHAQ) disability index (DI) over the study period	The CHAQ questionnaire consists of 30 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain is scored on a 4 point scale ranges from 0 to 3: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). An additional response of "not applicable" is available to indicate activities the participant is unable to perform because he/she is too young. The CHAQ-DI total score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (the worst). Higher scores indicate worse outcome	24, 72, 164 weeks
Changes in blood C-reactive Protein (CRP) concentrations over the study period	Serum concentrations of CRP is determined to assess the Pharmacodynamic (PD) effects of olokizumab	24, 72, 164 weeks
Proportion of patients with clinically inactive disease during the study according to American College of Rheumatology (ACR) criteria	Clinically inactive disease is defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy associated with JIA; absence of active uveitis; normal erythrocyte sedimentation rate (ESR) and/or C-reactive Protein (CRP); absence of disease activity according to the physician's global assessment of disease activity (VAS) scale; morning stiffness less than 15 minutes	24, 72, 164 weeks
Proportion of patients with pharmacologic remission during the study according to American College of Rheumatology (ACR) criteria	Pharmacologic remission is defined as a clinically inactive disease for at least 6 months. Clinically inactive disease is defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy associated with JIA; absence of active uveitis; normal erythrocyte sedimentation rate (ESR) and/or C-reactive Protein (CRP); absence of disease activity according to the physician's global assessment of disease activity (VAS) scale; morning stiffness less than 15 minutes	24, 72, 164 weeks
Proportion of patients with exacerbation of Juvenile Idiopathic Arthritis (JIA) according to Pediatric Rheumatology Collaborative Study Group (PRCSG)-Paediatric Rheumatology International Trials Organisation (PRINTO) criteria	Proportion of patients with exacerbation of JIA according to PRCSG-PRINTO criteria during the first 24 weeks of the study and the entire study Juvenile Idiopathic Arthritis (JIA) exacerbation is defined as a deterioration of 30% or more in 3 or more of the 6 JIAcore components, with an improvement of no more than 1 item by 30% or more JIAcore components include: Number of joints with active arthritis (defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by pain/tenderness); Number of joints with limitation of motion; Physician Global Assessment of Disease Activity (VAS 100 mm); Parent/Patient Global Assessment of Overall Well-being (VAS 100 mm); Physical function (Childhood Health Assessment Questionnaire - CHAQ); Erythrocyte Sedimentation Rate / C-reactive Protein (ESR/CRP)	24, 72, 164 weeks
Character of adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs)	Adverse events of special interest include: Infections (particularly serious infections), including tuberculosis (TB) and opportunistic infections; Malignancies; Elevations in blood lipid levels; Systemic injection-related reactions and hypersensitivity reactions, including anaphylaxis; Gastrointestinal perforation; Cardiovascular complications; Neutropenia, thrombocytopenia, leukopenia, and pancytopenia; Hepatotoxicity; Injection site reactions; Demyelinating events involving the peripheral or central nervous system	168, 172, 186 weeks
Frequency of adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs)	Adverse events of special interest include: Infections (particularly serious infections), including tuberculosis (TB) and opportunistic infections; Malignancies; Elevations in blood lipid levels; Systemic injection-related reactions and hypersensitivity reactions, including anaphylaxis; Gastrointestinal perforation; Cardiovascular complications; Neutropenia, thrombocytopenia, leukopenia, and pancytopenia; Hepatotoxicity; Injection site reactions; Demyelinating events involving the peripheral or central nervous system	168, 172, 186 weeks
Severity of adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs)	Adverse events of special interest include: Infections (particularly serious infections), including tuberculosis (TB) and opportunistic infections; Malignancies; Elevations in blood lipid levels; Systemic injection-related reactions and hypersensitivity reactions, including anaphylaxis; Gastrointestinal perforation; Cardiovascular complications; Neutropenia, thrombocytopenia, leukopenia, and pancytopenia; Hepatotoxicity; Injection site reactions; Demyelinating events involving the peripheral or central nervous system	168, 172, 186 weeks
Outcomes of adverse events (AEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs)	Adverse events of special interest include: Infections (particularly serious infections), including tuberculosis (TB) and opportunistic infections; Malignancies; Elevations in blood lipid levels; Systemic injection-related reactions and hypersensitivity reactions, including anaphylaxis; Gastrointestinal perforation; Cardiovascular complications; Neutropenia, thrombocytopenia, leukopenia, and pancytopenia; Hepatotoxicity; Injection site reactions; Demyelinating events involving the peripheral or central nervous system	168, 172, 186 weeks
Proportion of participants with adverse events (AEs)	Proportion of participants with AEs	168, 172, 186 weeks
Proportion of participants with serious adverse events (SAEs)	Proportion of participants with SAEs	168, 172, 186 weeks
Proportion of participants with clinically significant abnormalities in laboratory test results	Proportion of participants with clinically significant abnormalities in laboratory test results	168, 172, 186 weeks
Number of Participants With Laboratory Abnormalities	Laboratory parameters include: Hematology; Blood Biochemistry test; Interferon-gamma release assay; Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus tests; Coagulogram; Lipid profile blood test; Blood test for inflammatory markers; Blood test for antinuclear factor, rheumatoid factor, and anti-dsDNA antibodies; Complete Urinalysis; Pharmacokinetics (PK) analysis (Drug concentration); Blood test for anti-drug antibodies (ADA) and neutralizing antibodies (nAb); Blood test for cytokine levels (IL-6, IL-6R); HLA-B27 genetic blood test / HLA-B27 genotyping	168, 172, 186 weeks
Number of Participants With Vital Sign Abnormalities	Vital Signs include: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature. Abnormality in vital signs is based on investigator's discretion	168, 172, 186 weeks
Number of Participants With Physical Examination Abnormalities	Physical examination included: skin, heart, lungs, abdomen, liver, spleen, ENT organs, lymph nodes. Abnormality in physical examination is based on investigator's discretion	168, 172, 186 weeks
Proportion of participants who developed anti-drug antibodies (ADA) to the investigational product during the study and overall	Proportion of participants who developed anti-drug antibodies (ADA) to the investigational product during the study and overall	168, 172, 186 weeks
Proportion of participants who developed neutralizing antibodies (nAb) to the investigational product during the study and overall	Proportion of participants who developed neutralizing antibodies (nAb) to the investigational product during the study and overall	168, 172, 186 weeks

Collaborators and Investigators

• Sponsor: R-Pharm International, LLC
• Collaborators: R-Pharm; Keystat, LLC; Exacte Labs LLC
• Investigators: Study Director: Mikhail Samsonov, R-Pharm

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Arthritis; Autoimmune Diseases; Musculoskeletal Diseases; C-reactive protein (CRP); Juvenile Arthritis; interleukin-6 (IL-6); olokizumab; Rheumatic Diseases Connective Tissue Diseases
• Additional Relevant MeSH Terms: Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis; Arthritis, Juvenile; Autoimmune Diseases; Musculoskeletal Diseases
• Other Study ID Numbers: CL04041182

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No