Back to resultsA Study in Healthy Volunteers
Primary Purpose
Hepatitis B, Infectious Disease, Liver Diseases
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CRV431
Placebo
TDF
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B focused on measuring CRV431, Hepatitis B Virus, Hepatitis Virus
Eligibility 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
Sites / Locations
- Celerion, Inc
- Celerion, Inc
- Pinnacle Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
CRV431
Placebo
TDF
Arm Description
Either single or multiple doses of varying dose levels
300 mg TDF
Outcomes
Primary Outcome Measures
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT03596697
First Posted
July 3, 2018
Last Updated
November 30, 2021
Sponsor
Hepion Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03596697
Brief Title
A Study in Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 9, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
June 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hepion 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
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Infectious Disease, Liver Diseases
Keywords
CRV431, Hepatitis B Virus, Hepatitis Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRV431
Arm Type
Experimental
Arm Description
Either single or multiple doses of varying dose levels
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
TDF
Arm Type
Experimental
Arm Description
300 mg TDF
Intervention Type
Drug
Intervention Name(s)
CRV431
Intervention Description
Single or multiple dose(s) of CRV431
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single Placebo dose
Intervention Type
Drug
Intervention Name(s)
TDF
Intervention Description
Single or multiple dose(s) of TDF
Primary Outcome Measure Information:
Title
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events
Time Frame
56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Greytok
Organizational Affiliation
ContraVir Pharmaceutical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Celerion, Inc
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Celerion, Inc
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study in Healthy Volunteers
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