A Study in Healthy Volunteers
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
1 other identifier
interventional
92
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2019
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2018
CompletedFirst Posted
Study publicly available on registry
July 24, 2018
CompletedStudy Start
First participant enrolled
July 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2021
CompletedDecember 1, 2021
November 1, 2021
1.2 years
July 3, 2018
November 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events
56 days
Study Arms (3)
CRV431
EXPERIMENTALEither single or multiple doses of varying dose levels
Placebo
PLACEBO COMPARATORTDF
EXPERIMENTAL300 mg TDF
Interventions
Eligibility Criteria
You may qualify if:
- 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);
You may not qualify if:
- 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.
- Evidence of significant liver fibrosis or cirrhosis
- History of NAFLD or NASH
- Positive test for HDV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Celerion, Inc
Tempe, Arizona, 85283, United States
Celerion, Inc
Lincoln, Nebraska, 68502, United States
Pinnacle Clinical Research
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jill Greytok
ContraVir Pharmaceutical, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2018
First Posted
July 24, 2018
Study Start
July 9, 2019
Primary Completion
September 30, 2020
Study Completion
June 4, 2021
Last Updated
December 1, 2021
Record last verified: 2021-11