Hepatitis C Clinical Trial
Official title:
A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
Verified date | June 2022 |
Source | Atea Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: All: - Body mass index (BMI) of 18-35 kg/m2 - Must agree to use protocol-specified methods of contraception - Negative pregnancy test - Willing to comply with the study requirements and to provide written informed consent Additional for Part A: -18-55 years of age Additional for Part B: - 18-65 years of age - HCV genotype 1, 2 or 3 - Documented history compatible with chronic hepatitis C - HCV RNA = 10,000 IU/mL at Screening Exclusion Criteria: All: - Pregnant or breastfeeding - Abuse of alcohol or drugs - Use of other investigational drugs within 30 days of dosing - Other clinically significant medical conditions Additional for Part B: - Prior exposure to any HCV NS5A inhibitor - Cirrhosis - Co-infection with hepatitis B virus or HIV |
Country | Name | City | State |
---|---|---|---|
Belgium | Clinical Trial Site | Antwerp |
Lead Sponsor | Collaborator |
---|---|
Atea Pharmaceuticals, Inc. |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events | Number of subjects experiencing treatment-emergent adverse events | Through Day 6 for subjects in Part A | |
Primary | Incidence of Treatment-Emergent Adverse Events | Number of subjects experiencing treatment-emergent adverse events | Through 4 weeks after end of treatment for subjects in Part B | |
Primary | Antiviral Activity of AT-777 and AT-527 | Number of subjects who achieve plasma HCV RNA < lower limit of quantitation (LLOQ) and target not detected (TND) | Through 2 weeks of treatment for subjects in Part B | |
Secondary | AT-777 maximum plasma concentration (Cmax) | PK | Day 1 for subjects in Part A | |
Secondary | AT-777 area under the concentration-time curve (AUC) | PK | Day 1 for subjects in Part A | |
Secondary | Proportion of subjects achieving sustained virologic response (SVR) | SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment | 12 weeks after end of treatment for subjects in Part B |
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