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A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224

Primary Purpose

Steatohepatitis, Nonalcoholic

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ION224
Placebo
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Steatohepatitis, Nonalcoholic focused on measuring Non-Alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease Activity Score, Alanine Aminotransferase, Aspartate Aminotransferase

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or females greater than or equal to (≥) 18 and less than or equal to (≤) 75 years old at the time of informed consent
  • Body mass index ≥ 25 kg/m^2 and ≥ 22 kg/m^2 for participants of Asian race, as assessed during screening
  • Liver fat ≥ 10% as assessed by MRI-PDFF before randomization
  • Presence of NASH confirmed by centrally read liver biopsy
  • Weight loss < 5% after historical biopsy. Otherwise, weight loss < 5% in the previous 3 months prior to randomization
  • ALT and AST ≤ 200 units per liter (U/L) and confirmed to be stable
  • Total Bilirubin ≤ 1.3 milligrams per deciliter (mg/dL) and confirmed to be stable

Exclusion Criteria:

  • Prior or planned (during the Study Period) bariatric surgery or previous bariatric surgery within 2 years prior to screening
  • History of solid organ transplant

  • Screening laboratory values that would render a participant unsuitable for inclusion, including but not limited to:

    • Clinically significant albuminuria or proteinuria
    • Positive test for blood on urinalysis
    • Estimated glomerular filtration rate (eGFR) < 60 milliliters (mL)/minute (min)/1.73 square meter (m^2)
    • Hemoglobin A1c (HbA1c) > 9.5%
    • Platelet count < 170 × 10^9/liter (L)
  • Diagnosis of Gilbert's syndrome
  • Known history of or evidence of liver disease other than NASH
  • Clinical evidence of liver decompensation
  • Active SARS-CoV-2 infection (COVID-19) or confirmed SARS-CoV-2 infection-related complication within 8 weeks of Screening
  • Uncontrolled arterial hypertension
  • History of bleeding diathesis or coagulopathy
  • Participants with known intolerance to magnetic resonance imaging (MRI) or with conditions contraindicated for MRI Procedures
  • History of, or current hard drug or alcohol abuse within 2 years prior to Screening
  • Use of drugs historically associated with NAFLD for more than 2 weeks in the year prior to Screening
  • Use of obeticholic acid, ursodeoxycholic acid, icosapent ethyl, niacin, PCSK9 inhibitors, and bile acid sequestrants

  • Participants taking the following medicines UNLESS on a stable dose:

    • Anti-diabetic medications
    • statins, fenofibrate, and ezetimibe
    • Estrogen containing contraceptives
    • Glucagon-like peptide (GLP)-1 agonists
    • Pioglitazone
    • Vitamin E at doses ≤ 800 international unit (IU)/day
    • Herbal medicines, other prescription medicines, vitamins or supplements known to affect lipid metabolism
  • Other protocol-defined inclusion/exclusion criteria could apply

Sites / Locations

  • Arizona Liver Health-Chandler
  • Arizona Liver Health
  • Arizona Liver Health
  • Arkansas Gastroenterology - North Little Rock
  • GW Research, Inc.
  • National Research Institute - Gardena
  • National Research Institute
  • National Research Institute
  • National Research Institute Panorama City
  • National Research Institute - Santa Ana
  • South Denver Gastroenterology, PC
  • Excel Medical Clinical Trials, LLC
  • Tampa Bay Medical Research, Inc.
  • Southwest General Medical Center
  • Evolution Clinical Trials, INC
  • ClinCloud, LLC.
  • Floridian Clinical Research, LLC.
  • Advanced Pharma CR, LLC
  • La Salud Research
  • Entrust Clinical Research
  • Sensible Healthcare, LLC
  • Covenant Metabolic Specialists, LLC
  • Metabolic Research Institute, Inc.
  • Gastrointestinal Specialists of Georgia
  • Tandem Clinical Research GI
  • Tandem Clinical Research GI, LLC.
  • Tandem Clinical Research GI
  • Delta Research Partners
  • Louisiana Research Center, LLC
  • Southern Therapy and Advanced Research
  • Advanced Research Institute
  • Clarity Clinical Research
  • Tandem Clinical Research GI, LLC.
  • Cumberland Research Associates, LLC
  • Aventiv Research, Inc.
  • Clinical Research Institute of Ohio
  • WR-ClinSearch, LLC
  • Pinnacle Clinical Research
  • South Texas Research Institute
  • Dallas Diabetes Research Center
  • Velocity Clinical Research
  • South Texas Research Institute
  • R&H Clinical Research, Inc.
  • DHR Health Institute for Research and Development
  • Quality Research, Inc.
  • Pinnacle Clinical Research
  • Advanced Research Institute
  • Granger Medical Clinic
  • Advanced Research Institute
  • Manassas Clinical Research Center
  • FDI Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ION224

Placebo

Arm Description

Multiple doses of ION224 will be administered by SC injection once every 4 weeks for up to 49 weeks.

Multiple doses of matching placebo will be administered by SC injection once every 4 weeks for up to 49 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With at Least 2-point Reduction in Non-alcoholic Fatty Liver Disease Activity Score (NAS) With at least 1-point Improvement in Hepatocellular Ballooning or Lobular Inflammation, and Without Worsening in Fibrosis Stage at EOT
The NAS is a histology grading score composed on the assessment of steatosis (scale 0-3), hepatocellular ballooning (scale 0-2), and lobular inflammation (scale 0-3), with higher scores indicating more severe hepatitis. Worsening of fibrosis is defined as an increase in fibrosis of at least one stage on the Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).

Secondary Outcome Measures

Change From Baseline in Hepatic Fat Content Measurement as Evaluated by MRI-PDFF and Calculated by an Independent, Blinded-To-Treatment, Central Reader
Percentage of Participants Achieving Non-alcoholic Steatohepatitis (NASH) Resolution, as Defined by Scores of 0 for Both Ballooning and Inflammation by the NAS, and Without Worsening of Fibrosis, Assessed Through Liver Biopsy at the EOT
Percentage of Participants Achieving Reduction of at Least 1 Stage in the Fibrosis Score, and Without Worsening of Steatohepatitis by the NAS, Assessed Through Liver Biopsy at the EOT
Percentage of Participants Achieving a Combination of NASH Resolution and a 1 Stage Improvement in Fibrosis at the EOT
Percentage of Participants With Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Less than or Equal to (≤) 1.5 Upper Limit of Normal (ULN) at the EOT
Absolute Change From Baseline in Liver-related Laboratory Test - ALT
Absolute Change From Baseline in Liver-related Laboratory Test - AST
Absolute Change From Baseline in Liver-related Laboratory Test - Total Bilirubin
Absolute Change From Baseline in Liver-related Laboratory Test - Gamma-glutamyl Transferase
Absolute Change From Baseline in Plasma Fasting Lipid Profile Test - Triglyceride (TG)
Absolute Change From Baseline in Plasma Fasting Lipid Profile Test - Total Cholesterol
Absolute Change From Baseline in Plasma Fasting Lipid Profile Test - Low-density Lipoprotein-cholesterol (LDL-c)
Absolute Change From Baseline in Plasma Fasting Lipid Profile Test - High-density Lipoprotein-cholesterol (HDL-c)
Maximum Observed Plasma Concentration (Cmax) of ION224 and Metabolites
Time to Cmax (Tmax) of ION224 and Metabolites
Area Under the Plasma Concentration-time Curve (AUC) of ION224 and Metabolites
Plasma Half-life (t½) of ION224 and Metabolites

Full Information

First Posted
June 10, 2021
Last Updated
August 3, 2023
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04932512
Brief Title
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224
Official Title
An Adaptive Two-Part Phase 2, Multi-Center, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224 Administered Once Monthly in Adult Subjects With Confirmed Non-Alcoholic Steatohepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ionis Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the effect of multiple ION224 doses when administered by subcutaneous (SC) injection for 49 weeks (end of the treatment [EOT]) on non-alcoholic steatohepatitis (NASH) histologic improvement and to assess the effect on liver steatosis by magnetic resonance imaging-determined proton density fat fraction (MRI-PDFF), additional changes in NASH histologic features, liver biochemistry tests, and plasma lipid profile.
Detailed Description
This is a Phase 2, double-blind, randomized, placebo-controlled study of ION224 in up to 150 participants. The study consists of 3 periods: 1) Screening Period: Week -8 to Week -1 (up to 8 weeks); 2) Treatment Period up to Week 49; and 3) Post-Treatment Period: Week 50 to Week 62 (12 weeks). Initially, 48 patients will be enrolled in three different dose cohorts to receive ION224 or placebo every four weeks and based on safety and effects on liver steatosis (assessed at Week 15), two dose cohorts will be selected to be expanded. After dose selection, an additional 102 patients will be enrolled in the 2 selected dose cohorts and will receive ION224 or placebo for up to 49 weeks. Participants in the 3rd cohort (not selected) will continue to complete up to 49 weeks of treatment without any cohort expansion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Steatohepatitis, Nonalcoholic
Keywords
Non-Alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease Activity Score, Alanine Aminotransferase, Aspartate Aminotransferase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ION224
Arm Type
Experimental
Arm Description
Multiple doses of ION224 will be administered by SC injection once every 4 weeks for up to 49 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Multiple doses of matching placebo will be administered by SC injection once every 4 weeks for up to 49 weeks.
Intervention Type
Drug
Intervention Name(s)
ION224
Intervention Description
ION224 will be administered by SC injection.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
ION224-matching placebo solution will be administered by SC injection.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least 2-point Reduction in Non-alcoholic Fatty Liver Disease Activity Score (NAS) With at least 1-point Improvement in Hepatocellular Ballooning or Lobular Inflammation, and Without Worsening in Fibrosis Stage at EOT
Description
The NAS is a histology grading score composed on the assessment of steatosis (scale 0-3), hepatocellular ballooning (scale 0-2), and lobular inflammation (scale 0-3), with higher scores indicating more severe hepatitis. Worsening of fibrosis is defined as an increase in fibrosis of at least one stage on the Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).
Time Frame
Up to Week 49
Secondary Outcome Measure Information:
Title
Change From Baseline in Hepatic Fat Content Measurement as Evaluated by MRI-PDFF and Calculated by an Independent, Blinded-To-Treatment, Central Reader
Time Frame
Baseline up to Week 15, Week 29 and Week 49
Title
Percentage of Participants Achieving Non-alcoholic Steatohepatitis (NASH) Resolution, as Defined by Scores of 0 for Both Ballooning and Inflammation by the NAS, and Without Worsening of Fibrosis, Assessed Through Liver Biopsy at the EOT
Time Frame
Up to Week 49
Title
Percentage of Participants Achieving Reduction of at Least 1 Stage in the Fibrosis Score, and Without Worsening of Steatohepatitis by the NAS, Assessed Through Liver Biopsy at the EOT
Time Frame
Up to Week 49
Title
Percentage of Participants Achieving a Combination of NASH Resolution and a 1 Stage Improvement in Fibrosis at the EOT
Time Frame
Up to Week 49
Title
Percentage of Participants With Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Less than or Equal to (≤) 1.5 Upper Limit of Normal (ULN) at the EOT
Time Frame
Up to Week 49
Title
Absolute Change From Baseline in Liver-related Laboratory Test - ALT
Time Frame
Baseline up to Week 49
Title
Absolute Change From Baseline in Liver-related Laboratory Test - AST
Time Frame
Baseline up to Week 49
Title
Absolute Change From Baseline in Liver-related Laboratory Test - Total Bilirubin
Time Frame
Baseline up to Week 49
Title
Absolute Change From Baseline in Liver-related Laboratory Test - Gamma-glutamyl Transferase
Time Frame
Baseline up to Week 49
Title
Absolute Change From Baseline in Plasma Fasting Lipid Profile Test - Triglyceride (TG)
Time Frame
Baseline up to Week 49
Title
Absolute Change From Baseline in Plasma Fasting Lipid Profile Test - Total Cholesterol
Time Frame
Baseline up to Week 49
Title
Absolute Change From Baseline in Plasma Fasting Lipid Profile Test - Low-density Lipoprotein-cholesterol (LDL-c)
Time Frame
Baseline up to Week 49
Title
Absolute Change From Baseline in Plasma Fasting Lipid Profile Test - High-density Lipoprotein-cholesterol (HDL-c)
Time Frame
Baseline up to Week 49
Title
Maximum Observed Plasma Concentration (Cmax) of ION224 and Metabolites
Time Frame
Baseline up to Week 49
Title
Time to Cmax (Tmax) of ION224 and Metabolites
Time Frame
Baseline up to Week 49
Title
Area Under the Plasma Concentration-time Curve (AUC) of ION224 and Metabolites
Time Frame
Baseline up to Week 49
Title
Plasma Half-life (t½) of ION224 and Metabolites
Time Frame
Baseline up to Week 49

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females greater than or equal to (≥) 18 and less than or equal to (≤) 75 years old at the time of informed consent Body mass index ≥ 25 kg/m^2 and ≥ 22 kg/m^2 for participants of Asian race, as assessed during screening Liver fat ≥ 10% as assessed by MRI-PDFF before randomization Presence of NASH confirmed by centrally read liver biopsy Weight loss < 5% after historical biopsy. Otherwise, weight loss < 5% in the previous 3 months prior to randomization ALT and AST ≤ 200 units per liter (U/L) and confirmed to be stable Total Bilirubin ≤ 1.3 milligrams per deciliter (mg/dL) and confirmed to be stable Exclusion Criteria: Prior or planned (during the Study Period) bariatric surgery or previous bariatric surgery within 2 years prior to screening History of solid organ transplant Screening laboratory values that would render a participant unsuitable for inclusion, including but not limited to: Clinically significant albuminuria or proteinuria Positive test for blood on urinalysis Estimated glomerular filtration rate (eGFR) < 60 milliliters (mL)/minute (min)/1.73 square meter (m^2) Hemoglobin A1c (HbA1c) > 9.5% Platelet count < 170 × 10^9/liter (L) Diagnosis of Gilbert's syndrome Known history of or evidence of liver disease other than NASH Clinical evidence of liver decompensation Active SARS-CoV-2 infection (COVID-19) or confirmed SARS-CoV-2 infection-related complication within 8 weeks of Screening Uncontrolled arterial hypertension History of bleeding diathesis or coagulopathy Participants with known intolerance to magnetic resonance imaging (MRI) or with conditions contraindicated for MRI Procedures History of, or current hard drug or alcohol abuse within 2 years prior to Screening Use of drugs historically associated with NAFLD for more than 2 weeks in the year prior to Screening Use of obeticholic acid, ursodeoxycholic acid, icosapent ethyl, niacin, PCSK9 inhibitors, and bile acid sequestrants Participants taking the following medicines UNLESS on a stable dose: Anti-diabetic medications statins, fenofibrate, and ezetimibe Estrogen containing contraceptives Glucagon-like peptide (GLP)-1 agonists Pioglitazone Vitamin E at doses ≤ 800 international unit (IU)/day Herbal medicines, other prescription medicines, vitamins or supplements known to affect lipid metabolism Other protocol-defined inclusion/exclusion criteria could apply
Facility Information:
Facility Name
Arizona Liver Health-Chandler
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Liver Health
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Liver Health
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Arkansas Gastroenterology - North Little Rock
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
GW Research, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
National Research Institute - Gardena
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Facility Name
National Research Institute
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
National Research Institute Panorama City
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
National Research Institute - Santa Ana
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
South Denver Gastroenterology, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Excel Medical Clinical Trials, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Tampa Bay Medical Research, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Southwest General Medical Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Evolution Clinical Trials, INC
City
Hialeah Gardens
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
ClinCloud, LLC.
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Floridian Clinical Research, LLC.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
La Salud Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Entrust Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Sensible Healthcare, LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Covenant Metabolic Specialists, LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Tandem Clinical Research GI
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70363
Country
United States
Facility Name
Tandem Clinical Research GI, LLC.
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Tandem Clinical Research GI
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Delta Research Partners
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Southern Therapy and Advanced Research
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Advanced Research Institute
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Clarity Clinical Research
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Tandem Clinical Research GI, LLC.
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Aventiv Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Clinical Research Institute of Ohio
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
WR-ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Pinnacle Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
South Texas Research Institute
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520
Country
United States
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Velocity Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
South Texas Research Institute
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
R&H Clinical Research, Inc.
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
DHR Health Institute for Research and Development
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
Quality Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Granger Medical Clinic
City
Riverton
State/Province
Utah
ZIP/Postal Code
84096
Country
United States
Facility Name
Advanced Research Institute
City
Sandy
State/Province
Utah
ZIP/Postal Code
84092
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
FDI Clinical Research
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224

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