Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06719310 | Phase Ib/IIa Clinical Study of ACC017 Tablets | PHASE1 | RECRUITING | 36 | — | — | Aug 28, 2024 | Nov 1, 2025 | Dec 5, 2024 | 1 | China |
Proportion of patients with HIV-1 RNA viral load \<50 copies/mL
Cτ,ss is defined as the steady-state plasma drug concentration at the end of the dosing interval after the last administration of a given dose on the monotherapy and combination therapy periods.
Cmin,ss is defined as the minimum steady-state plasma drug concentration after the last dose of monotherapy.
Cmax,ss is defined as the maximum steady-state plasma drug concentration after the last dose of monotherapy.
AUC0-τ,ss is defined as the steady-state area under the plasma concentration-time curve from time zero to the any dosing interval of monotherapy.
Tmax,ss is defined as the time to reach steady-state maximum plasma concentration during monotherapy period.
MRT0-τ,ss is defined as the steady-state mean residence time from time zero to any dosing interval of monotherapy.
| Arm | Type | Description |
|---|---|---|
| Participant group 1 | EXPERIMENTAL | Stage one: ACC017 (Dose 1) Stage two: ACC017 (Dose 1)+FTC/TAF (200mg/25mg) QD |
| Participant group 2 | EXPERIMENTAL | Stage one: ACC017 (Dose 2) Stage two: ACC017 (Dose 2)+FTC/TAF (200mg/25mg) QD |
| Participant group 3 | EXPERIMENTAL | Stage one: ACC017 (Dose 3) Stage two: ACC017 (Dose 3)+FTC/TAF (200mg/25mg) QD |
| Participant group 4 | PLACEBO_COMPARATOR | Stage one: Placebo |
| Name | Type | Description |
|---|---|---|
| ACC017+FTC/TAF | DRUG | ACC017+FTC/TAF |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Willing to sign the informed consent and agree to comply to the study procedures and requests 2. Age range between 18 and 65 years old at the time of signing informed consent, regardless of gender 3. Body weight ≥40 kg, and BMI range between 18.5\~29.9 kg/m2 (including the bo...