Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma (AIRCULES)

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Moderate-to-severe Asthma

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Lunsekimig

• Study Type: Interventional
• Enrollment (Actual): 685
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1121
    • Investigational Site Number : 0320005
  • Buenos Aires, Argentina, 1414
    • Investigational Site Number : 0320004
  • Buenos Aires, Argentina, 1425
    • Investigational Site Number : 0320001
  • Mendoza, Argentina, 5500
    • Investigational Site Number : 0320009
  • San Miguel de Tucumán, Argentina, 4000
    • Investigational Site Number : 0320008
  • Santa Fe, Argentina, 3000
    • Investigational Site Number : 0320010
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, 1886
      • Investigational Site Number : 0320007
    • La Plata, Buenos Aires, Argentina, 1900
      • Investigational Site Number : 0320003
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Investigational Site Number : 0320002
    • Rosario, Santa Fe Province, Argentina, 2000
      • Investigational Site Number : 0320006
• Brazil
  • Rio de Janeiro, Brazil, 22241-180
    • CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006
  • São Paulo, Brazil, 05403-900
    • Incor - Instituto do Coracao- Site Number : 0760011
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40060-330
      • Associacao Proar- Site Number : 0760003
  • Goiás
    • Goiânia, Goiás, Brazil, 74605-020
      • Universidade Federal de Goias- Site Number : 0760007
  • Paraná
    • Curitiba, Paraná, Brazil, 80030-110
      • Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070-550
      • Inst de Medicina Integral Professor Fernando Figueira- Site Number : 0760009
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89030-101
      • Hospital Dia do Pulmão- Site Number : 0760005
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Investigational Site Number : 1240003
    • Stoney Creek, Ontario, Canada, L8G 2V6
      • Investigational Site Number : 1240005
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Investigational Site Number : 1240004
    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • Investigational Site Number : 1240001
• Chile
  • Los Ríos Region
    • Valdivia, Los Ríos Region, Chile, 5110683
      • Investigational Site Number : 1520010
  • Maule Region
    • Talca, Maule Region, Chile, 3465584
      • Investigational Site Number : 1520001
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500587
      • Investigational Site Number : 1520006
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500692
      • Investigational Site Number : 1520005
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500698
      • Investigational Site Number : 1520004
    • Santiago, Reg Metropolitana de Santiago, Chile, 7580206
      • Investigational Site Number : 1520009
    • Santiago, Reg Metropolitana de Santiago, Chile, 7750495
      • Investigational Site Number : 1520002
  • Región de Valparaíso
    • Quillota, Región de Valparaíso, Chile, 2260877
      • Investigational Site Number : 1520008
    • Viña del Mar, Región de Valparaíso, Chile, 2520598
      • Investigational Site Number : 1520011
• China
  • Beijing, China, 100144
    • Investigational Site Number : 1560011
  • Changchun, China, 130021
    • Investigational Site Number : 1560010
  • Changsha, China, 410015
    • Investigational Site Number : 1560017
  • Chengdu, China, 610041
    • Investigational Site Number : 1560008
  • Guangzhou, China, 510120
    • Investigational Site Number : 1560001
  • Guangzhou, China, 510150
    • Investigational Site Number : 1560009
  • Hefei, China, 230032
    • Investigational Site Number : 1560006
  • Hohhot, China, 010050
    • Investigational Site Number : 1560014
  • Mianyang, China, 621000
    • Investigational Site Number : 1560018
  • Nanchang, China, 330006
    • Investigational Site Number : 1560007
  • Pingxiang, China, 337055
    • Investigational Site Number : 1560002
  • Shanghai, China, 200433
    • Investigational Site Number : 1560013
  • Shenyang, China, 110004
    • Investigational Site Number : 1560015
  • Wenzhou, China, 325027
    • Investigational Site Number : 1560005
  • Wuhan, China, 430030
    • Investigational Site Number : 1560003
  • Xuzhou, China, 221006
    • Investigational Site Number : 1560004
  • Yangzhou, China, 225000
    • Investigational Site Number : 1560016
  • Zhanjiang, China, 524004
    • Investigational Site Number : 1560012
• India
  • Coimbatore, India, 641028
    • Investigational Site Number : 3560002
  • Delhi, India, 110 029
    • Investigational Site Number : 3560006
  • Hyderabad, India, 500084
    • Investigational Site Number : 3560009
  • Kanpur, India, 208002
    • Investigational Site Number : 3560008
  • Kozhikode, India, 673008
    • Investigational Site Number : 3560007
  • Lucknow, India, 226006
    • Investigational Site Number : 3560003
  • Nagpur, India, 441203
    • Investigational Site Number : 3560001
  • Pune, India, 411057
    • Investigational Site Number : 3560004
• Israel
  • Ashkelon, Israel, 7830604
    • Investigational Site Number : 3760006
  • Haifa, Israel, 3104802
    • Investigational Site Number : 3760001
  • Haifa, Israel, 3436212
    • Investigational Site Number : 3760008
  • Jerusalem, Israel, 9103102
    • Investigational Site Number : 3760003
  • Jerusalem, Israel, 9112001
    • Investigational Site Number : 3760002
  • Petah Tikva, Israel, 4941492
    • Investigational Site Number : 3760010
  • Ramat Gan, Israel, 5262100
    • Investigational Site Number : 3760009
  • Rehovot, Israel, 7610001
    • Investigational Site Number : 3760004
  • Tel Aviv, Israel, 6423906
    • Investigational Site Number : 3760007
• Japan
  • Fukushima, Japan, 960-1295
    • Investigational Site Number : 3920008
  • Higashiōmi, Japan, 527-8505
    • Investigational Site Number : 3920003
  • Kyoto, Japan, 610-0113
    • Investigational Site Number : 3920006
  • Kyoto, Japan, 612-8555
    • Investigational Site Number : 3920009
  • Miyazaki, Japan, 889-1692
    • Investigational Site Number : 3920012
  • Chiba
    • Kamogawa, Chiba, Japan, 296-0041
      • Investigational Site Number : 3920004
  • Kagawa-ken
    • Sakaidechō, Kagawa-ken, Japan, 762-8550
      • Investigational Site Number : 3920002
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 231-0801
      • Investigational Site Number : 3920010
  • Tokyo
    • Chūō, Tokyo, Japan, 104-0031
      • Investigational Site Number : 3920011
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Investigational Site Number : 3920005
• Mexico
  • Chihuahua City, Mexico, 31000
    • Investigational Site Number : 4840002
  • Durango, Mexico, 34000
    • Investigational Site Number : 4840003
  • Mérida, Mexico, 97070
    • Investigational Site Number : 4840007
  • Veracruz, Mexico, 91910
    • Investigational Site Number : 4840008
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44100
      • Investigational Site Number : 4840001
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 66465
      • Investigational Site Number : 4840004
  • Querétaro
    • San Juan del Río, Querétaro, Mexico, 76800
      • Investigational Site Number : 4840005
• South Africa
  • Benoni, South Africa, 1500
    • Investigational Site Number : 7100004
  • Benoni, South Africa, 1500
    • Investigational Site Number : 7100005
  • Cape Town, South Africa, 7530
    • Investigational Site Number : 7100003
  • Cape Town, South Africa, 7700
    • Investigational Site Number : 7100002
  • Durban, South Africa, 4001
    • Investigational Site Number : 7100001
  • Lochner ROAD, South Africa, PRETORIA
    • Investigational Site Number : 7100006
• South Korea
  • Seoul, South Korea, 06351
    • Investigational Site Number : 4100005
  • Seoul-teukbyeolsi
    • Seoul, Seoul-teukbyeolsi, South Korea, 03722
      • Investigational Site Number : 4100001
    • Seoul, Seoul-teukbyeolsi, South Korea, 03080
      • Investigational Site Number : 4100002
    • Seoul, Seoul-teukbyeolsi, South Korea, 05030
      • Investigational Site Number : 4100004
    • Seoul, Seoul-teukbyeolsi, South Korea, 05505
      • Investigational Site Number : 4100006
    • Seoul, Seoul-teukbyeolsi, South Korea, 08308
      • Investigational Site Number : 4100003
• Turkey (Türkiye)
  • Akdeniz, Turkey (Türkiye), 33070
    • Investigational Site Number : 7920001
  • Bursa, Turkey (Türkiye), 16059
    • Investigational Site Number : 7920006
  • Istanbul, Turkey (Türkiye), 34098
    • Investigational Site Number : 7920002
  • Istanbul, Turkey (Türkiye), 34854
    • Investigational Site Number : 7920003
  • Izmir, Turkey (Türkiye), 35110
    • Investigational Site Number : 7920004
  • Kayseri, Turkey (Türkiye), 38039
    • Investigational Site Number : 7920007
  • İzmit, Turkey (Türkiye), 41001
    • Investigational Site Number : 7920005
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Investigational Site Number : 8260003
  • Bradford, United Kingdom, BD9 6RJ
    • Investigational Site Number : 8260008
  • Bristol, United Kingdom, BS8 2RA
    • Investigational Site Number : 8260009
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Investigational Site Number : 8260001
  • Edinburgh, City of
    • Glasgow, Edinburgh, City of, United Kingdom, G12 0YN
      • Investigational Site Number : 8260004
  • Surrey
    • Chertsey, Surrey, United Kingdom, KT16 0PZ
      • Investigational Site Number : 8260005
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Allergy, Asthma & Immunology Associates- Site Number : 8400009
    • Yuma, Arizona, United States, 85364
      • Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072
  • California
    • Lancaster, California, United States, 93534
      • Antelope Valley Clinical Trials- Site Number : 8400020
    • Northridge, California, United States, 91324
      • Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032
    • San Francisco, California, United States, 94102
      • Optimus Medical- Site Number : 8400046
    • San Jose, California, United States, 95117
      • Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038
    • Thousand Oaks, California, United States, 91360
      • Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Allianz Research Institute CO- Site Number : 8400026
    • Englewood, Colorado, United States, 80110
      • Velocity Clinical Research - Denver- Site Number : 8400027
    • Wheat Ridge, Colorado, United States, 80033
      • Western States Clinical Research- Site Number : 8400014
  • Florida
    • Cutler Bay, Florida, United States, 33157
      • Beautiful Minds Clinical Research Center- Site Number : 8400049
    • Hialeah, Florida, United States, 33010
      • Qway Research - Hialeah- Site Number : 8400015
    • Miami, Florida, United States, 33145
      • Clintex Research Group - Miami - Coral Way- Site Number : 8400048
    • Miami, Florida, United States, 33184
      • High Quality Research- Site Number : 8400039
    • Miami, Florida, United States, 33186
      • Innovations Biotech- Site Number : 8400040
    • Miami, Florida, United States, 33186
      • New Access Medical Center- Site Number : 8400043
    • Miami Lakes, Florida, United States, 33014
      • Deluxe Health Center- Site Number : 8400045
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute - New Port Richey- Site Number : 8400044
    • Pembroke Pines, Florida, United States, 33024
      • Pines Care Research Center- Site Number : 8400057
    • Sarasota, Florida, United States, 34239
      • Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
  • Georgia
    • Calhoun, Georgia, United States, 30701
      • Appalachian Clinical Research- Site Number : 8400050
  • Illinois
    • Champaign, Illinois, United States, 61822
      • PMG Research of Christie Clinic- Site Number : 8400066
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Velocity Clinical Research Lafayette Site Number : 8400060
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Javara - Privia Medical Group - Annapolis- Site Number : 8400033
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital- Site Number : 8400034
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System - Ann Arbor- Site Number : 8400004
  • Minnesota
    • Mankato, Minnesota, United States, 56001
      • Javara - Mankato Clinic- Site Number : 8400051
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Midwest Clinical Research Center - St. Louis- Site Number : 8400006
  • New York
    • Middletown, New York, United States, 10940
      • Circuit Clinical - Middletown Medical - 111 Maltese Drive- Site Number : 8400065
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai- Site Number : 8400058
  • North Carolina
    • Charlotte, North Carolina, United States, 28273
      • Carolina Clinical Research - Charlotte- Site Number : 8400071
    • Charlotte, North Carolina, United States, 28287
      • Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
    • Gastonia, North Carolina, United States, 28054
      • Clinical Research Of Gastonia- Site Number : 8400013
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Bernstein Clinical Research Center- Site Number : 8400016
    • Toledo, Ohio, United States, 43617
      • Asthma & Allergy Center - Toledo- Site Number : 8400017
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research- Site Number : 8400021
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research - Medford- Site Number : 8400059
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Clinical Research Associates of Central PA - Dubois- Site Number : 8400069
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
    • Pottstown, Pennsylvania, United States, 19464
      • Circuit Clinical - PMSI Comprehensive Healthcare for Life - Pottstown - Medical Drive- Site Number : 8400064
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • VitaLink Research - Anderson - East Greenville- Site Number : 8400063
    • Charleston, South Carolina, United States, 29414
      • Velocity Clinical Research - Charleston- Site Number : 8400061
  • Texas
    • Austin, Texas, United States, 78759
      • Orion Clinical Research- Site Number : 8400001
    • Boerne, Texas, United States, 78006
      • South Texas Medical Research Institute - TTS Research- Site Number : 8400010
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center- Site Number : 8400002
    • El Paso, Texas, United States, 79903
      • Western Sky Medical Research- Site Number : 8400023
    • McKinney, Texas, United States, 75069
      • Metroplex Pulmonary and Sleep Center- Site Number : 8400022
    • Plano, Texas, United States, 75093
      • VAST Clinical Research- Site Number : 8400062

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA guidelines Steps 4 and 5
• Participants with existing treatment with moderate-to-high doses of ICS therapy for in combination with at least 1 but no more than 2 additional controller medications at least 3 months with a stable dose ≥1 month prior to Visit 1
• At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy
• ACQ-5 score more than 1.5 at Screening (Visit 1)

Exclusion Criteria:

• Chronic obstructive or other lung diseases (eg, COPD, idiopathic pulmonary fibrosis, etc) which may impair lung function, or another diagnosed pulmonary or systemic disease.
• Current smoker or former smoker with cessation within 6 months of Screening or history of >10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening.
• Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening
• Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening
• For participants on chronic OCS use for the maintenance treatment of asthma: history of a serious infection requiring hospitalization within the past 12 months prior to Randomization (Visit 2).
• Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening
• Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2	Drug: Placebo; Pharmaceutical form: solution for injection Route of administration: subcutaneous
Experimental: Lunsekimig Dose1 interval 1; Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1	Drug: Lunsekimig; Pharmaceutical form: solution for injection Route of administration: subcutaneous
Experimental: Lunsekimig Dose 1 interval 2; Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2	Drug: Lunsekimig; Pharmaceutical form: solution for injection Route of administration: subcutaneous
Experimental: Lunsekimig Dose 2 interval 1; Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1	Drug: Lunsekimig; Pharmaceutical form: solution for injection Route of administration: subcutaneous
Experimental: Lunsekimig Dose 2 interval 2; Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2	Drug: Lunsekimig; Pharmaceutical form: solution for injection Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Annualized rate of asthma exacerbation events	From baseline to week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pre-bronchodilator (BD) FEV1		From baseline to week 48
Change from baseline in post-BD FEV1		From baseline to week 48
The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)		From baseline to week 48
Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score	ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control	From baseline to week 48
Change from baseline in ACQ-5 score		From baseline to week 48
Change from baseline in FeNO		From baseline to week 48
Time to first asthma exacerbation		From baseline to week 48
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit		From baseline to week 48
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores	Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.	From baseline to week 48
Change from baseline in ACQ scores		From baseline to week 48
Average number of inhalations per day of short-acting beta 2-agoinst (SABA), Low dose ICS/formoterol or ICS/SABA for symptom relief		From baseline to week 48
Proportion of participants with ≥4-point improvement in SGRQ score		From baseline to week 48
Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores		From baseline to week 48
Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores		From baseline to week 48
Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score		From baseline to week 48
Serum lunsekimig concentrations		From baseline to week 52
Anti-drug antibodies (ADA) against lunsekimig		From baseline to week 52
Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)		From baseline to week 52

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinial Science & Operations, Sanofi

Publications and helpful links

Helpful Links

• DRI16762 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Actual): February 23, 2026
• Study Completion (Actual): March 11, 2026

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: DRI16762; U1111-1280-5514 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

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