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A Study in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03596697
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Hepion Pharmaceuticals, Inc.

Study Description
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Brief Summary:
This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers. The second part of the study will be a single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in stable HBV patients.

Condition or disease Intervention/treatment Phase
Hepatitis B Infectious Disease Liver Diseases Drug: CRV431 Drug: Placebo Drug: TDF Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Partially-blinded, Placebo-controlled, Ascending Sequential Dose Groups, Single Dose Study of the Safety, Tolerability and Pharmacokinetics of CRV431, Alone and In Combination With Tenofovir Disoproxil Fumarate in Healthy Subjects, With a Pilot Study of Multiple Ascending Sequential Doses in Healthy Volunteer Subjects
Actual Study Start Date : July 9, 2019
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : June 4, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CRV431
Either single or multiple doses of varying dose levels
 Drug: CRV431
Single or multiple dose(s) of CRV431
Placebo Comparator: Placebo Drug: Placebo
Single Placebo dose
Experimental: TDF
300 mg TDF
 Drug: TDF
Single or multiple dose(s) of TDF


Outcome Measures
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Primary Outcome Measures :
  1. Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events [ Time Frame: 56 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Capable of giving written informed consent
  • Willing and able to complete all study requirements
  • Healthy male or female between 18 and 55 years of age (inclusive);
  • Body mass index 16 to 32 kg/m2 (inclusive);

Exclusion Criteria:

  • Positive test for HCVAb or HIVAb. For healthy subjects only: positive test for HBsAg
  • Current or history of abuse of alcohol or illicit drugs
  • Received an investigational drug, vaccine or medical device within 90 days prior to first dose of study drug.

Additional Exclusion Criteria for HBV Pilot Subjects Only:

  • Evidence of significant liver fibrosis or cirrhosis
  • History of NAFLD or NASH
  • Positive test for HDV
Contacts and Locations
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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): NCT03596697


Locations
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United States, Arizona
Celerion, Inc
Tempe, Arizona, United States, 85283
United States, Nebraska
Celerion, Inc
Lincoln, Nebraska, United States, 68502
United States, Texas
Pinnacle Clinical Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Hepion Pharmaceuticals, Inc.
Investigators
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Study Director: Jill Greytok ContraVir Pharmaceutical, Inc.
More Information
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Responsible Party: Hepion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03596697    
Other Study ID Numbers: CTRV-CRV431-101
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hepion Pharmaceuticals, Inc.:
CRV431
Hepatitis B Virus
Hepatitis Virus
Additional relevant MeSH terms:
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Hepatitis B
Communicable Diseases
Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Blood-Borne Infections
Hepadnaviridae Infections
DNA Virus Infections
Disease Attributes
Pathologic Processes