Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-47D11 · 1 trial · 1 indication
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug.
Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.
| Arm | Type | Description |
|---|---|---|
| Part A: Group 1: ABBV-47D11 Dose A | EXPERIMENTAL | Participants will receive ABBV-47D11 Dose A on Day 1. |
| Part A: Group 1: Placebo for ABBV-47D11 | PLACEBO_COMPARATOR | Participants will receive placebo for ABBV-47D11 on Day 1. |
| Part A: Group 2: ABBV-47D11 Dose B | EXPERIMENTAL | Participants will receive ABBV-47D11 Dose B on Day 1. |
| Part A: Group 2: Placebo for ABBV-47D11 | PLACEBO_COMPARATOR | Participants will receive placebo for ABBV-47D11 on Day 1. |
| Part A: Group 3: ABBV-47D11 Dose C | EXPERIMENTAL | Participants will receive ABBV-47D11 Dose C on Day 1. |
| Part A: Group 3: Placebo for ABBV-47D11 | PLACEBO_COMPARATOR | Participants will receive placebo for ABBV-47D11 on Day 1. |
| Part B: Group 1: ABBV-2B04 Dose A | EXPERIMENTAL | Participants will receive ABBV-2B04 Dose A on Day 1. |
| Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11 | EXPERIMENTAL | Participants will receive ABBV-2B04 Dose A in combination with ABBV-47D11 on Day 1. |
| Part B: Group 1: Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1. |
| Part B: Group 2: ABBV-2B04 Dose B | EXPERIMENTAL | Participants will receive ABBV-2B04 Dose B on Day 1. |
| Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11 | EXPERIMENTAL | Participants will receive ABBV-2B04 Dose B in combination with ABBV-47D11 on Day 1. |
| Part B: Group 2: Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1. |
| Name | Type | Description |
|---|---|---|
| ABBV-47D11 | DRUG | Intravenous (IV) infusion. |
| Placebo for ABBV-47D11 | DRUG | Intravenous (IV) infusion. |
| ABBV-2B04 | DRUG | Intervenous (IV) Infusion |
| Placebo for ABBV-2B04 | DRUG | Intervenous (IV) Infusion |
Inclusion Criteria: * Confirmed SARS-CoV-2 infection based on initial nucleic acid or antigen testing from respiratory swab, saliva, or other bodily fluid within 7 days prior to randomization. * Must have \>= 1 symptom associated with COVID-19 with an onset of \<= 8 days prior to randomization. * H...
ABBV-47D11 is an investigational small molecule being developed for the treatment of CoronaVirus Disease-2019 (COVID-19). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
ABBV-47D11 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV.
ABBV-47D11 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 trial has been completed to assess its safety and how it moves through the body.
ABBV-47D11 has one completed Phase 1 trial, NCT04644120, which evaluated the drug alone and in combination with another investigational drug in adult participants with COVID-19. The trial enrolled 25 participants across the United States, Hungary, Israel, Netherlands, and Puerto Rico.
No, ABBV-47D11 and ABBV-2B04 are different investigational drugs. In clinical trial NCT04644120, they were studied both alone and in combination to assess how they move through the body in participants with COVID-19.