Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE (Lupus)

May 22, 2024 updated by: Kangpu Biopharmaceuticals, Ltd.

A Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients With Systemic Lupus Erythematosus

Study Title

A phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to assess the safety and tolerability, pharmacokinetics and preliminary efficacy of KPG-818 in patients with mild to moderate systemic lupus erythematosus

Study Overview

Status

Status

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

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

This is a Phase 1b/2a multicenter study to evaluate the safety, PK, PD, and clinical efficacy of KPG-818 in patients with SLE. The trial will consist of 2 parts: Phase 1b, a multiple-ascending dose (MAD) study; and Phase 2a, a proof of concept (POC) study.

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 (Actual)

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.
64

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.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Anniston Medical Clinic
      • Birmingham, Alabama, United States, 35205
        • University of Alabama - Birmingham
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
      • Coral Gables, Florida, United States, 33134
        • Hope Clinical Trials, Inc.
      • Cutler Bay, Florida, United States, 33189
        • JY Research Institute Inc
      • Hollywood, Florida, United States, 33020
        • Osis Clinical Research
      • Miami, Florida, United States, 33136
        • SouthCoast Research Center Inc
      • Miami, Florida, United States, 33155
        • D & H National Research Centers
      • Miami Lakes, Florida, United States, 33014
        • Charisma Medical and Research Center
      • Miami Lakes, Florida, United States, 33014
        • San Marcus Research Clinic
      • Orlando, Florida, United States, 32808
        • Omega Research MetroWest LLC
      • Tampa, Florida, United States, 33606
        • Clinical Research of West Florida
    • Georgia
      • College Park, Georgia, United States, 30329
        • Oracle Clinical Research
    • Ohio
      • Vandalia, Ohio, United States, 54377
        • STAT Research
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Shelby Research LLC
    • Texas
      • Houston, Texas, United States, 77084
        • Accurate Clinical Management
      • Houston, Texas, United States, 77089
        • Accurate Clinical Research LLC
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute

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

Description

Inclusion criteria are listed as follows:

  1. Age≥18
  2. BMI between 18-40kg/m²
  3. Diagnosed with SLE according to the 2019 EULAR/ACR criteria for SLE
  4. Meeting SLE activity requirements
  5. Males and females childbearing potential must agree to use contraception methods

  6. All patients must:

    1. Understand that KPG-818 could have potential teratogenic risk.
    2. Agree not to share KPG-818 with another person.
    3. Be counseled about pregnancy precautions and risks of fetal exposure as described in the Pregnancy Prevention Plan.
  7. Patients must agree not to donate blood (or any component of blood) from 3 months before Screening until 3 months after the last dose of KPG-818.
  8. Patients must be willing to comply with precautions to reduce the risk of COVID-19 infection and to undergo COVID-19 PCR test.

Exclusion criteria are listed as follows:

  1. Use of any prohibited medications within the pre-specified time
  2. Patients must meet exclusionary lab criteria
  3. Active and/or unstable neuropsychiatric SLE
  4. Active or history of severe systemic bacterial, viral, fungal, mycobacterial, or parasitic infections within 6 months prior to Screening
  5. Current or recent sign or symptoms of infections, or severe viral infections
  6. Conditions predisposes patient to infection
  7. Active TB or positive QuantiFERON®-TB Gold test
  8. Patients with malignancy and antiphospholipid syndrome history
  9. Inflammatory joint or skin disease, mixed connective tissue disease, scleroderma, and/or overlap syndromes, or acute or chronic disease
  10. Concomitant condition that required systemic corticosteroid use within 1 year before Screening
  11. Alcohol or drug abuse history
  12. Positive urine drug test at screening
  13. History or planned major surgery
  14. Pregnant or breastfeeding female
  15. Signs or symptoms of COVID-19 infection
  16. Known allergic reaction to any of the ingredients for study drug or placebo

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: Quadruple

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.
Placebo Comparator: Placebo arm
After providing informed consent, patients will be assessed for study eligibility at the Screening visit. A total of 8 to 12 patients will be randomized to receive this dose level of KPG-818 in a double-blind fashion. Patients will receive treatment for 12 weeks with a 4-week safety follow-up. Capsules of this level of dosage will be taken orally in the morning once a day. All patients will return for follow-up visits after their final dose. The total duration of study participation for each patient (from Screening through Follow-up visit) is anticipated to be approximately 20 weeks.
Drug: Placebo
This is the comparative arm.
Active Comparator: KPG-818 low dose
After providing informed consent, patients will be assessed for study eligibility at the Screening visit. A total of 8 to 12 patients will be randomized to receive this dose level of KPG-818 in a double-blind fashion. Patients will receive treatment for 12 weeks with a 4-week safety follow-up. Capsules of this level of dosage will be taken orally in the morning once a day. All patients will return for follow-up visits after their final dose. The total duration of study participation for each patient (from Screening through Follow-up visit) is anticipated to be approximately 20 weeks.
Drug: KPG-818 low dose
The dose levels may be modified according to the results from phase 1b of the study. Dose adjustment is allowed during the study.
Active Comparator: KPG-818 mid dose
After providing informed consent, patients will be assessed for study eligibility at the Screening visit. A total of 8 to 12 patients will be randomized to receive this dose level of KPG-818 in a double-blind fashion. Patients will receive treatment for 12 weeks with a 4-week safety follow-up. Capsules of this level of dosage will be taken orally in the morning once a day. All patients will return for follow-up visits after their final dose. The total duration of study participation for each patient (from Screening through Follow-up visit) is anticipated to be approximately 20 weeks.
Drug: KPG-818 mid dose
The dose levels may be modified according to the results from phase 1b of the study. Dose adjustment is allowed during the study.
Active Comparator: KPG-818 high dose
After providing informed consent, patients will be assessed for study eligibility at the Screening visit. A total of 8 to 12 patients will be randomized to receive this dose level of KPG-818 in a double-blind fashion. Patients will receive treatment for 12 weeks with a 4-week safety follow-up. Capsules of this level of dosage will be taken orally in the morning once a day. All patients will return for follow-up visits after their final dose. The total duration of study participation for each patient (from Screening through Follow-up visit) is anticipated to be approximately 20 weeks.
Drug: KPG-818 high dose
The dose levels may be modified according to the results from phase 1b of the study. Dose adjustment is allowed during the study.

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
Measure Description
Time Frame
Safety assessment by the occurrence of adverse events (AEs)
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
To calculate the occurrence rate of adverse events (AEs)
4 weeks for phase Ib and 16 weeks for phase IIa
Safety assessment by the changes from baseline in laboratory parameters
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
To calculate the occurrence rate of out of normal ranges of laboratory parameter changes from baseline.
4 weeks for phase Ib and 16 weeks for phase IIa
Safety assessment by out of normal range of vital signs
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
To calculate the occurrence rate of out of normal range of vital signs from baseline.
4 weeks for phase Ib and 16 weeks for phase IIa
Safety assessment by out of normal range of ECG results
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
To calculate the occurrence rate of out of normal range of ECG results.
4 weeks for phase Ib and 16 weeks for phase IIa
PK profile of time to peak (Tmax) for KPG-818 and KPG-818H (if applicable).
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
This will be measured on Day 1 after dose administration and after the plasma concentration reaches a steady state.
4 weeks for phase Ib and 16 weeks for phase IIa
PK profile of peak plasma concentration (Cmax) for KPG-818 and KPG-818H (if applicable).
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
This will be measured on Day 1 after dose administration.
4 weeks for phase Ib and 16 weeks for phase IIa
PK profile of elimination half-life (t1/2) for KPG-818 and KPG-818H (if applicable).
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
This will be measured on Day 1 after dose administration and after the plasma concentration reaches a steady state.
4 weeks for phase Ib and 16 weeks for phase IIa
PK profile of the area under the concentration-time curve (AUC0-24h) for KPG-818 and KPG-818H (if applicable).
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
This will be measured on Day 1 after dose administration.
4 weeks for phase Ib and 16 weeks for phase IIa
PK profile of the mean retention time (MRT) for KPG-818 and KPG-818H (if applicable).
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
This will be measured after the plasma concentration reaches a steady state.
4 weeks for phase Ib and 16 weeks for phase IIa
PK profile of trough concentrations at steady state (Css_min) for KPG-818 and KPG-818H (if applicable).
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
This will be measured after the plasma concentration reaches a steady state.
4 weeks for phase Ib and 16 weeks for phase IIa
PK profile of peak concentrations at steady state (Css_max) for KPG-818 and KPG-818H (if applicable).
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
This will be measured after the plasma concentration reaches a steady state.
4 weeks for phase Ib and 16 weeks for phase IIa
PK profile of the area under the concentration-time curve at steady state (AUCτ, AUC0-∞) for KPG-818 and KPG-818H (if applicable).
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
This will be measured after the plasma concentration reaches a steady state.
4 weeks for phase Ib and 16 weeks for phase IIa
PK profile of the clearance (CL/F) for KPG-818 and KPG-818H (if applicable).
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
This will be measured after the plasma concentration reaches a steady state.
4 weeks for phase Ib and 16 weeks for phase IIa
PK profile of the apparent volume of distribution ((Vz/F) for KPG-818 and KPG-818H (if applicable).
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
This will be measured after the plasma concentration reaches a steady state.
4 weeks for phase Ib and 16 weeks for phase IIa
PK profile of the cumulative coefficient (R) for KPG-818 and KPG-818H (if applicable).
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
This will be measured after the plasma concentration reaches a steady state.
4 weeks for phase Ib and 16 weeks for phase IIa
Assess the proportion of patients with improvement of clinical scores of SELENA-SLEDAI (safety of estrogens in lupus national assessment-systemic lupus erythematosus disease activity index) improvement ≥ 4 points from baseline at Week 12.
Time Frame: 16 weeks for phase IIa
To calculate the proportion of patients with SELENA-SLEDAI (safety of estrogens in lupus national assessment-systemic lupus erythematosus disease activity index) improvement ≥ 4 points from baseline at Week 12. Note: the SELENA-SLEDAI scale ranges from 0~105, with 105 as the highest disease activity.
16 weeks for phase IIa

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
Measure Description
Time Frame
Mean change from baseline in PGA (Physician Global Assessment) score at Week 12.
Time Frame: 16 weeks for phase IIa
Mean change from baseline in PGA (Physician Global Assessment) score at Week 12. Note: the PGA is a visual scale for the physician to mark, from 0mm to 100mm, with 0mm being no disease activity and 100mm being the extreme disease activity.
16 weeks for phase IIa
The proportion of patients with a ≥ 50% reduction from baseline in CLASI (Cutaneous Lupus erythematosus disease Area and Severity Index) activity score at Week 12, in patients with baseline CLASI activity score ≥ 10.
Time Frame: 16 weeks for phase IIa
The proportion of patients with a ≥ 50% reduction from baseline in CLASI (Cutaneous Lupus erythematosus disease Area and Severity Index) activity score at Week 12, in patients with baseline CLASI activity score ≥ 10. Note: the total CLASI score ranges from 0 to 114, with 0 being the least disease activity and 114 being the most.
16 weeks for phase IIa
Number of patients with adverse event at Week 12
Time Frame: 12 weeks for phase IIa
Number of patients with adverse event at Week 12
12 weeks for phase IIa
Number of patients with adverse event at Week 16.
Time Frame: 16 weeks for phase IIa
Number of patients with adverse event at Week 16.
16 weeks for phase IIa
The PK endpoint of the measurement of area under the curve (AUC) at Week 12 (AUC0-last) for assessment of KPG-818 and KPG-818H (if applicable).
Time Frame: 12 weeks for phase IIa
The PK endpoint of the measurement of area under the curve (AUC) at Week 12 (AUC0-last) for assessment of KPG-818 and KPG-818H (if applicable).
12 weeks for phase IIa
The PK endpoint of the maximum observed concentration (Cmax) at Week 12 for assessment of KPG-818 and KPG-818H (if applicable)
Time Frame: 12 weeks for phase IIa
The PK endpoint of the maximum observed concentration (Cmax) at Week 12 for assessment of KPG-818 and KPG-818H (if applicable)
12 weeks for phase IIa
The PK endpoint of time to Cmax (tmax) at Week 12 for assessment of KPG-818 and KPG-818H (if applicable)
Time Frame: 12 weeks for phase IIa
The PK endpoint of time to Cmax (tmax) at Week 12 for assessment of KPG-818 and KPG-818H (if applicable).
12 weeks for phase IIa
The PK endpoint of Ctrough throughout the dosing period for assessment of KPG-818 and KPG-818H (if applicable)
Time Frame: 12 weeks for phase IIa
The PK endpoint of Ctrough throughout the dosing period for assessment of KPG-818 and KPG-818H (if applicable)
12 weeks for phase IIa
The PK endpoint of serum concentrations by scheduled timepoints for assessment of KPG-818 and KPG-818H (if applicable)
Time Frame: 12 weeks for phase IIa
The PK endpoint of serum concentrations by scheduled timepoints for assessment of KPG-818 and KPG-818H (if applicable)
12 weeks for phase IIa

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Explore the mean change from baseline in potential biomarker, i.e. Aiolos, of KPG-818 in PBMCs and CD19+ B Cells at Week 2.
Time Frame: 2 weeks for phase Ib
Explore the mean change from baseline in potential biomarker of Aiolos of KPG-818 in PBMCs and CD19+ B Cells at Week 2.
2 weeks for phase Ib
Explore the mean change from baseline in potential biomarker, i.e. Ikaros, of KPG-818 in PBMCs and CD19+ B Cells at Week 2.
Time Frame: 2 weeks for phase Ib
Explore the mean change from baseline in potential biomarker, i.e. Ikaros, of KPG-818 in PBMCs and CD19+ B Cells at Week 2.
2 weeks for phase Ib
Explore the mean change from baseline in potential biomarker, i.e. CRBN proteins, of KPG-818 in PBMCs and CD19+ B Cells at Week 2.
Time Frame: 2 weeks for phase Ib
Explore the mean change from baseline in potential biomarker, i.e. CRBN proteins, of KPG-818 in PBMCs and CD19+ B Cells at Week 2.
2 weeks for phase Ib
Mean change from baseline in potential biomarker, i.e. CRBN proteins, of KPG-818 in PBMCs and CD19+ B cells at week 12
Time Frame: 12 weeks for phase IIa
Mean change from baseline in potential biomarker, i.e. CRBN proteins, of KPG-818 in PBMCs and CD19+ B cells at week 12
12 weeks for phase IIa
Mean change from baseline in potential biomarker, i.e. Aiolos, of KPG-818 in PBMCs and CD19+ B cells at week 12
Time Frame: 12 weeks for phase IIa
Mean change from baseline in potential biomarker, i.e. Aiolos, of KPG-818 in PBMCs and CD19+ B cells at week 12
12 weeks for phase IIa
Mean change from baseline in potential biomarker, i.e. Ikaros, of KPG-818 in PBMCs and CD19+ B cells at week 12
Time Frame: 12 weeks for phase IIa
Mean change from baseline in potential biomarker, i.e. Ikaros, of KPG-818 in PBMCs and CD19+ B cells at week 12
12 weeks for phase IIa
Mean change from baseline in absolute counts of CD 19+ B cell and CD3+ T cell at week 12
Time Frame: 12 weeks for phase IIa
Mean change from baseline in absolute counts of CD 19+ B cell and CD3+ T cell at week 12
12 weeks for phase IIa
Mean change from baseline in IgA, IgG and IgM in serum at week 12
Time Frame: 12 weeks for phase IIa
Mean change from baseline in IgA, IgG and IgM in serum at week 12
12 weeks for phase IIa
Dose regimens for a Phase 2b/phase 3 study
Time Frame: 4 weeks for phase Ib and 16 weeks for phase IIa
Dose regimens for a Phase 2b/phase 3 study
4 weeks for phase Ib and 16 weeks for phase IIa

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.
Kangpu Biopharmaceuticals, Ltd.

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: MD, Kangpu Biopharmaceuticals, Ltd.

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.
June 3, 2021

Primary Completion (Actual)

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 18, 2023

Study Completion (Actual)

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.
August 18, 2023

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).
November 12, 2020

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.
November 22, 2020

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.
November 24, 2020

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.
May 23, 2024

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.
May 22, 2024

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.
May 1, 2024

More Information

Terms related to this study

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.
  • KPG-818-SLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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