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ML Risk
ABBV-CLS-616 · 1 trial · 1 indication
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Part 1: Group 1 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose A or placebo after fasting on Day 1 and will be confined for 19 days. |
| Part 1: Group 2 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose B or placebo after fasting on Day 1 and will be confined for 19 days. |
| Part 1: Group 3 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose C or placebo after fasting on Day 1 and will be confined for 8 days. |
| Part 1: Group 4 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose D or placebo after fasting on Day 1 and will be confined for 8 days. |
| Part 1: Group 5 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose E or placebo after fasting on Day 1 and will be confined for 8 days. |
| Part 1: Group 6 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose F or placebo after fasting on Day 1 and will be confined for 8 days. |
| Part 2: Group 7 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose G or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 2: Group 8 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose H or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 2: Group 9 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose D or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 2: Group 10 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose E or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 2: Group 11 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose F or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 3: Sequence 1 | EXPERIMENTAL | In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 after fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, without fasting and will be confined for 8 days. |
| Part 3: Sequence 2 | EXPERIMENTAL | In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 without fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 8 days. |
| Part 4: Itraconazole | EXPERIMENTAL | In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 7 days. In Period 2, participants will receive Itraconazole daily for 10 days without fasting and will receive ABBV-CLS-616 Dose C on Day 4 after fasting. Participants will be confined for 11 days. |
| Name | Type | Description |
|---|---|---|
| ABBV-CLS-616 | DRUG | Oral Tablet |
| Placebo | DRUG | Oral Tablet |
| Itraconazole | DRUG | Oral Capsule |
Inclusion Criteria: * Part 2 only: Participant must have normal platelet count at screening and upon initial confinement. * Part 2 only: Participant must not have known or suspected coagulopathy, or prothrombin time (PT)/activated partial thromboplastin time (aPTT)/international normalized ratio (I...
ABBV-CLS-616 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development to assess its safety, tolerability, and interactions when administered as oral tablets. The drug is not approved for any indication and remains in early-stage clinical testing.
ABBV-CLS-616 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy adult participants.
ABBV-CLS-616 is in Phase 1 clinical development. A Phase 1 study has been completed, involving 110 healthy adult participants in the United States. The drug is investigational and has not been approved by regulatory authorities.
ABBV-CLS-616 has one completed clinical trial, registered as NCT06698926. This Phase 1 study assessed the safety, tolerability, and interactions of ABBV-CLS-616 oral tablets in healthy adult participants. The trial was randomized, double-blind, and controlled, with 110 participants enrolled in the United States.
ABBV-CLS-616 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed Phase 1 trial evaluated its safety and tolerability in healthy volunteers, but the drug has not yet progressed through the later stages of clinical testing required for regulatory approval.