Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CDI-31244 · 2 trials · 2 indications
The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after treatment
The safety and the tolerability of single and multiple oral doses of CDI-31244 through number of AEs observed in HV and HCV infected subjects
| Arm | Type | Description |
|---|---|---|
| CDI-31244 + SOF/VEL | EXPERIMENTAL | CDI-31244 in combination with SOF/VEL |
| Cohort 1A HV | EXPERIMENTAL | CDI-31244 20 mg active or placebo single dose (SD) |
| Cohort 2A HV | EXPERIMENTAL | CDI-31244 50 mg active or placebo SD |
| Cohort 3A HV | EXPERIMENTAL | CDI-31244 100 mg active or placebo SD |
| Cohort 4A HV | EXPERIMENTAL | CDI-31244 200 mg active or placebo SD; food effect |
| Cohort 5A HV | EXPERIMENTAL | CDI-31244 400 mg active or placebo SD |
| Cohort 6A HV | EXPERIMENTAL | CDI-31244 200 mg active or placebo multiple dose (MD) |
| Cohort 7A HV | EXPERIMENTAL | CDI-31244 200 mg active or placebo MD |
| Cohort 8A HV | EXPERIMENTAL | CDI-31244 400 mg active or placebo MD |
| Cohort 1B HCV genotype (GT) 1 | EXPERIMENTAL | CDI-31244 400 mg active or placebo MD |
| Cohort 2B HCV GT 1 | EXPERIMENTAL | CDI-31244 600 mg active or placebo MD |
| Cohort 3B HCV GT 1 | EXPERIMENTAL | CDI-31244 800 mg active or placebo MD |
| Name | Type | Description |
|---|---|---|
| CDI-31244 | DRUG | investigational drug |
| SOF/VEL | DRUG | sofosbuvir and velpatasvir fixed dose combination |
| Placebo | DRUG | no active ingredients |
Key Inclusion Criteria: Documented chronic HCV GT 1 infection; Serum HCV RNA \>1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis Key Exclusion Criteria: Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV) infection; History of use of a...