Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ANA773 · 1 trial · 1 indication
Evaluate the Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients
| Arm | Type | Description |
|---|---|---|
| Part A, Group 1 Healthy Volunteer | ACTIVE_COMPARATOR | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 200 mg of ANA773 (n=6) or placebo (n=2) |
| Part A, Group 2 Healthy Volunteer | ACTIVE_COMPARATOR | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 400 mg of ANA773 (n=6) or placebo (n=2) |
| Part A, Group 3 Healthy Volunteer | ACTIVE_COMPARATOR | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 800 mg of ANA773 (n=6) or placebo (n=2) |
| Part A, Group 4 Healthy Volunteer | ACTIVE_COMPARATOR | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 1200 mg of ANA773 (n=6) or placebo (n=2) |
| Part A, Group 5 Healthy Volunteer | ACTIVE_COMPARATOR | a single oral dose (Period 1) and multiple oral doses every other day (4 administrations) (Period 2) of 1600 mg of ANA773 (n=6) or placebo (n=2) |
| Part B, Group 6 HCV Infected Patient | ACTIVE_COMPARATOR | multiple oral doses(14 administrations) every other day of 2000 mg of ANA773 (n=6) or placebo (n=2) |
| Part B, Group 7 HCV Infected Patient | ACTIVE_COMPARATOR | multiple oral doses(14 administrations) every other day of 1200 mg of ANA773 (n=6) or placebo (n=2) |
| Part B, Group 8 HCV Infected Patient | ACTIVE_COMPARATOR | multiple oral doses(14 administrations) every other day of 1600 mg of ANA773 (n=6) or placebo (n=2) |
| Part B, Group 9 HCV Infected Patient | ACTIVE_COMPARATOR | multiple oral doses(5 administrations) every other day of 2000 mg of ANA773 (n=8) or placebo (n=2) |
| Name | Type | Description |
|---|---|---|
| ANA773 | DRUG | ANA773 Tosylate Capsule |
| Placebo | DRUG | Matching Placebo Capsule |
Part A Inclusion: * Male or female, ages 18 to 65 years * No clinically significant abnormalities * No serious or severe chronic conditions * Non-smokers Part A Exclusion: * Female subjects who are pregnant or breast-feeding * History of significant medical condition that could interfere with stu...
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ANA773 is an investigational small molecule being studied for the treatment of HCV Infection, a viral infection of the liver. It was evaluated in a Phase 1 clinical trial that included healthy volunteers and patients with hepatitis C virus to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics.
ANA773 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The drug is currently in Phase 1 clinical development for the treatment of HCV Infection.
ANA773 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a randomized, double-blind, active-controlled study involving 75 participants. The drug is investigational and has not been approved by regulatory authorities for any use.
ANA773 has been studied in one completed clinical trial, identified as NCT01211626. This Phase 1 study was conducted in the Netherlands and enrolled 75 participants, including healthy volunteers and patients with HCV Infection. The trial assessed safety, tolerability, pharmacokinetics, and pharmacodynamics.
ANA773 is a distinct investigational small molecule developed by Roche Holding AG. No alternative names for ANA773 have been reported in the available clinical trial information. It is being studied specifically for HCV Infection and is not known to be identical to any other marketed drug.