First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

October 14, 2026 updated by: Daiichi Sankyo

Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

DS-3939a is an antibody drug conjugate (ADC) being developed for the treatment of malignant tumors. This is a first-in-human, dose-escalating clinical study divided into 2 parts: the Dose Escalation Part (Part 1) and the Dose Expansion Part (Part 2).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
590

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: (US Sites) Daiichi Sankyo Contact for Clinical Trial Information
  • Phone Number: 908-992-6400
  • Email: CTRinfo@dsi.com

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
  • Canada
      • Montreal, Canada, H4A 3J1
        • Withdrawn
        • McGill University Health Center
      • Toronto, Canada, M5G2M9
        • Recruiting
        • Princess Margaret Cancer Center
  • China
      • Beijing, China, 100142
        • Withdrawn
        • Beijing Cancer Hospital
      • Changchun, China, 130000
        • Withdrawn
        • Jilin Cancer Hospital
      • Changsha, China, 410013
        • Withdrawn
        • Hunan Cancer Hospital
      • Chengdu, China, 610041
        • Recruiting
        • Sichuan Cancer Hospital
      • Hangzhou, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
      • Jinan, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
      • Nanchang, China, 330209
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
      • Neijiang, China, 641000
        • Recruiting
        • The Second Peoples Hospital of Neijiang
      • Shanghai, China, 200120
        • Recruiting
        • Shanghai East Hospital
      • Tianjin, China, 300060
        • Withdrawn
        • Tianjin Medical University Cancer Institute & Hospital
      • Wuhan, China, 430022
        • Withdrawn
        • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
      • Xi'an, China, 710061
        • Withdrawn
        • The First Affiliated Hospital of Xiâan Jiaotong University
      • Xiangyang, China, 441021
        • Recruiting
        • Xiangyang Central Hospital
  • France
      • Lyon, France, 69008
        • Recruiting
        • Centre Léon Bérard
      • Lyon, France, 69008
        • Withdrawn
        • Centre Léon Bérard
      • Marseille, France, 13005
        • Recruiting
        • Assistance Publique- de Marseille
      • Saint-Herblain, France, 44800
        • Recruiting
        • Ico - Site René Gauducheau
      • Strasbourg, France, 67091
        • Withdrawn
        • Chu Strasbourg
      • Toulouse, France, 31059
        • Recruiting
        • Institut Claudius Regaud
        • Contact:
          • Principle Investigator
      • Villejuif, France, 94805
        • Recruiting
        • Institut Gustave Roussy
  • Japan
      • Chūōku, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
          • See Central Contact
      • Hirakata-shi, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital
        • Contact:
          • Principal Investigator
      • Kashiwa, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
          • See Central Contact
      • Kumamoto, Japan, 861-4193
        • Recruiting
        • Saiseikai Kumamoto Hospital
        • Contact:
          • Principal Investigator
      • Kōtoku, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of Jfcr
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute
      • Sapporo, Japan, 003-0804
        • Recruiting
        • Nho Hokkaido Cancer Center
        • Contact:
          • Principal Investigator
      • Sendai, Japan, 981-0914
        • Recruiting
        • Sendai Kousei Hospital
      • Sunto-gun, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center
        • Contact:
          • Principal Investigator
      • Ōsaka-sayama, Japan, 589-8511
        • Recruiting
        • Kindai University Hospital
  • South Korea
      • Goyang, South Korea, 10408
        • Recruiting
        • National Cancer Center
        • Contact:
          • Site Coordinator
      • Seongnam-si, South Korea, 13620
        • Withdrawn
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 05505
        • Withdrawn
        • Asan Medical Center
  • Spain
      • Barcelona, Spain, 8035
        • Recruiting
        • Hospital Universitari Vall D'Hebron
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain, 28041
        • Withdrawn
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon Y Cajal
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga
      • Pozuelo de Alarcón, Spain, 28223
        • Recruiting
        • Next Madrid
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
  • United States
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Principal Investigator
      • Sarasota, Florida, United States, 34232
        • Withdrawn
        • Florida Cancer Specialists
    • Georgia
      • Locust Grove, Georgia, United States, 30248
        • Withdrawn
        • Piedmont Cancer Institute
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Withdrawn
        • Henry Ford Health System
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care
        • Contact:
          • Principal Investigator
    • New York
      • New York, New York, United States, 10029
        • Withdrawn
        • Icahn School of Medicine Mt Sinai
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
          • Principal Investigator
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas M.D. Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute, University of Utah
        • Contact:
          • Principal Investigator
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Withdrawn
        • Virginia Cancer Specialists
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • The Medical College of Wisconsin, INC
      • Milwaukee, Wisconsin, United States, 53226
        • Withdrawn
        • The Medical College of Wisconsin, INC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sign and date the main Informed Consent Form (ICF).
  • Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment.
  • Has adequate organ function.
  • Measurable disease based on RECIST V1.1.
  • Eastern Cooperative Oncology Group performance status score of 0 or 1.

Additional inclusion criteria for Part 1

  • Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors.

Additional inclusion criteria for Part 2

  • Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria

  • Is able to provide either of the following baseline tumor samples:

    1. Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or

      • Fresh core needle biopsy sample
      • Fresh biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy, or other procedures as long as the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual.

    2. FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the main ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the Sponsor Medical Monitor should be consulted regarding the adequacy of the sample.

Exclusion Criteria:

  • Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
  • Has spinal cord compression or clinically active central nervous system metastases.
  • Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.
  • Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids.
  • Has active or uncontrolled human immunodeficiency virus (HIV) infection.
  • Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection.
  • Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
  • Has an active (ie, symptomatic and/or on-treatment), known, or suspected autoimmune disease.
  • Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Escalation (Part 1)

Participants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a starting at 1 mg/kg.
Drug: DS-3939a

One IV infusion Q3W on Day 1 of each 21-day cycle
Experimental: Dose Expansion (Part 2)

Multiple expansion cohorts targeting various advanced solid tumors.
Drug: DS-3939a

One IV infusion Q3W on Day 1 of each 21-day cycle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a
Time Frame: Approximately 3 months after first dosing
Approximately 3 months after first dosing
Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2)
Time Frame: Up to approximately 31 months
Up to approximately 31 months
PSA50 Response Rate Following Treatment with DS-3939a (Part 2; CRPC only)
Time Frame: Up to approximately 31 months
Up to approximately 31 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 1)
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Disease Control Rate Following Treatment With DS-3939a
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Duration of Response Following Treatment With DS-3939a
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Time to Response Following Treatment With DS-3939a
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Progression Free Survival Following Treatment With DS-3939a
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Overall Survival Following Treatment With DS-3939a
Time Frame: Up to approximately 31 months
Up to approximately 31 months
TA-MUC1 Expression by Immunohistochemistry Following Treatment With DS-3939a
Time Frame: At Cycle 1 Day 1
At Cycle 1 Day 1
Area Under the Plasma Concentration Curve (AUC) Following Treatment With DS-3939a
Time Frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Maximum Plasma Concentration (Cmax) Following Treatment With DS-3939a
Time Frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Time to Maximum Plasma Concentration (Tmax) Following Treatment With DS-3939a
Time Frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Minimum Observed Concentration (Ctrough) Following Treatment With DS-3939a
Time Frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Terminal Half-Life (T1/2) Following Treatment With DS-3939a
Time Frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)
Number of Participants With Treatment-emergent Anti-drug Antibodies Following Treatment With DS-3939a
Time Frame: Up to approximately 47 months
Up to approximately 47 months
PSA50 Response Rate Following Treatment with DS-3939a (Part 1; CRPC only)
Time Frame: Up to approximately 31 months
Up to approximately 31 months
PSA30 and PSA90 Response Rate Following Treatment with DS-3939a (CRPC only)
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Time to PSA Progression Following Treatment with DS-3939a (CRPC only)
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Radiographic Progression-free Survival (PCWG 3) Following Treatment with DS-3939a (CRPC only)
Time Frame: Up to approximately 31 months
Up to approximately 31 months
Overall Survival Following Treatment with DS-3939a (CRPC only)
Time Frame: Up to approximately 31 months
Up to approximately 31 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Global Clinical Leader, Daiichi Sankyo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 18, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS3939-077
  • 2023-507937-14-00 (Ctis)
  • 2023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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