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Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic Patients

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ClinicalTrials.gov Identifier: NCT03747224
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in dyslipidemic patients including familial hypercholesterolemia and severe hypertriglyceridemia.

Condition or disease Intervention/treatment Phase
Dyslipidemias Familial Hypercholesterolemia Hypertriglyceridemia Drug: ARO-ANG3 Drug: sterile normal saline (0.9% NaCl) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ARO-ANG3 in Adult Healthy Volunteers and in Dyslipidemic Patients
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ARO-ANG3 Drug: ARO-ANG3
single or multiple doses of ARO-ANG3 by subcutaneous (sc) injections

Placebo Comparator: Placebo Drug: sterile normal saline (0.9% NaCl)
calculated volume to match active treatment




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment [ Time Frame: Up to 113 (+/- 3 days) post-dose ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of ARO-ANG3: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Single dose phase: Up to 48 hours post-dose ]
  2. PK of ARO-ANG3: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Single dose phase: Up to 48 hours post-dose ]
  3. PK of ARO-ANG3: Terminal Elimination Half-Life (t1/2) [ Time Frame: Single dose phase: Up to 48 hours post-dose ]
  4. PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) [ Time Frame: Single dose phase: Up to 48 hours post-dose ]
  5. PK of ARO-ANG3: Area Under the Plasma Concentration Versus Time Curve From Zero to infinity (AUCinf) [ Time Frame: Single dose phase: Up to 48 hours post-dose ]
  6. Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline [ Time Frame: Baseline, Up to Day 113 (+/- 3 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
  • Willing to provide written informed consent and to comply with study requirements
  • On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study
  • Normal electrocardiogram (ECG) at Screening

Exclusion Criteria:

  • Clinically significant health concerns
  • Regular use of alcohol within one month prior to Screening
  • Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
  • Recent use of illicit drugs
  • Use of more than two tobacco/nicotine containing or cannabis products per month within 6 months prior to drug administration (applicable only to Normal Healthy Volunteers)

NOTE: additional inclusion/exclusion criteria may apply, per protocol


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747224


Contacts
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Contact: Medical Monitor +1-626-304-3400 clinicaltrials@arrowheadpharma.com

Locations
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Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Kerry Kearins    +61 2 95157236    Kerry.Kearins@health.nsw.gov.au   
Principal Investigator: David Sullivan, MD         
Australia, South Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5000
Contact: Denise Healy    +61 409877807    Deanise.Healy@sa.gov.au   
Principal Investigator: Peter Clifton, MD         
Australia
Linear Clinical Research Recruiting
Nedlands, Australia, 6009
Contact: Nicola Norton, RN    +61 (0) 414 416 034    nnorton@linear.org.au   
Principal Investigator: Gerald Watts, MD         
New Zealand
Auckland Clinical Studies Limited Recruiting
Grafton, Auckland, New Zealand, 1010
Contact: Shuruthi Balachandran    + 64 9 373 3474    Krypton@clinicalstudies.co.nz   
Principal Investigator: Christian Schwabe, MD         
Middlemore Hospital Recruiting
Papatoetoe, Aukland, New Zealand, 2025
Contact: Alice Cassidy    +64 9 276 0044    Alice.Cassidy@mmclintrials.nz   
Principal Investigator: John Baker, MD         
Lipid & Diabetes Research Group Recruiting
Christchurch, New Zealand, 8011
Contact: Patrice McGregor    +64 3 364 1376    Patrice.McGregor@cdhb.health.nz   
Principal Investigator: Russell Scott, MD         
Sponsors and Collaborators
Arrowhead Pharmaceuticals

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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03747224     History of Changes
Other Study ID Numbers: AROANG1001
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipoproteinemia Type II
Dyslipidemias
Hypertriglyceridemia
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias