Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-333 · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Single dose of 400 mg |
| Group 2 | EXPERIMENTAL | Single dose of 800 mg after safety evolution of Group I |
| Group 3 | EXPERIMENTAL | Single dose of 1200 mg after safety evolution of Group 2 |
| Group 4 | EXPERIMENTAL | Single dose of 1600 mg after safety evolution of Group 3 |
| Group 5 | PLACEBO_COMPARATOR | Single dose of placebo |
| 1. ABT-333 Tablet | ACTIVE_COMPARATOR | Three 400mg ABT-333 Tablets, BID |
| 2. ABT-333 Tablet | ACTIVE_COMPARATOR | Four 400mg ABT-333 Tablets, BID |
| 3. Placebo | PLACEBO_COMPARATOR | Three or four placebo tablets, BID |
| 1. ABT-333 Capsule vs ABT-333 Tablet | ACTIVE_COMPARATOR | 400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose |
| 1 | OTHER | Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole |
| 2 | OTHER | Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID |
| 3 | OTHER | Healthy volunteers, receiving 600mg ABT-333 or placebo, BID |
| 4 | OTHER | Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID |
| 5 | OTHER | Healthy volunteers, receiving 1600mg ABT-333 or placebo, BID\* \*After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed. |
| Name | Type | Description |
|---|---|---|
| ABT-333 | DRUG | Tablet, see arms for interventional description |
| Placebo | DRUG | Tablet, see arms for interventional description. |
| ABT-333 Tablet | DRUG | See Arm Description for more information. |
| ABT-333 Capsule | DRUG | See arm description for more information |
| ketoconazole | DRUG | Tablet, see arms for intervention description |
Inclusion Criteria: * Subject has provided written consent. * Subject is in general good health. Exclusion Criteria: * See above for main selection criteria.
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ABT-333 is an investigational small molecule being developed for the treatment of HCV infection, also referred to as HCV infections. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
ABT-333 is being developed by Abbott Laboratories, a company traded on the stock exchange under the ticker symbol ABT. The drug is in Phase 1 clinical development for the treatment of HCV infection.
ABT-333 is in Phase 1 clinical development. It is an investigational drug for the treatment of HCV infection and has not yet been approved by regulatory authorities. All completed trials for ABT-333 are Phase 1 studies.
ABT-333 has been studied in four completed Phase 1 clinical trials, including NCT00768690, NCT00895102, NCT00909636, and NCT00919490. These trials evaluated the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers with HCV infection.
ABT-333 is not known to have any alternative names. It is an investigational small molecule being developed by Abbott Laboratories for the treatment of HCV infection, and it is currently in Phase 1 clinical development.