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Company decision: re-evaluation of risk vs benefit (based on animal data)
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This study will assess how safe ABBV-990 is and how ABBV-990 moves through the body of adult healthy participants. Adverse Events will be assessed.
ABBV-990 is an investigational drug being developed for the treatment of SARS-CoV-2 infections. Participants are randomly assigned to one of the 5 treatment groups. Each group receives different treatment. There is 1 in 4 chance that participants are assigned to placebo. Approximately 40 adult healthy volunteers will be enrolled in a single site in the United States.
Participants will receive oral tablet of ABBV-990 or matching placebo on Day 1 and followed for approximately 30 days.
Participants will be confined for 5 days. Adverse Events and blood tests will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive ABBV-990 Dose A or matching placebo. |
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| Group 2 | Experimental | Participants will receive ABBV-990 Dose B or matching placebo. |
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| Group 3 | Experimental | Participants will receive ABBV-990 Dose C or matching placebo. |
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| Group 4 | Experimental | Participants will receive ABBV-990 Dose D or matching placebo. |
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| Group 5 | Experimental | Participants will receive ABBV-990 Dose E or matching placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-990 | Drug | Oral Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) | 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. | Up to approximately 30 days |
| Maximum Observed Plasma Concentration (Cmax) of ABBV-990 | Cmax of ABBV-990. | Up to approximately 5 days |
| Time to Cmax (Tmax) of ABBV-990 | Tmax of ABBV-990. | Up to approximately 5 days |
| Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-990 | Apparent terminal phase elimination rate constant of ABBV-990. | Up to approximately 5 days |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-990 | Terminal phase elimination half-life of ABBV-990. | Up to approximately 5 days |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-990 | AUCt of ABBV-990. | Up to approximately 5 days |
| AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990 | AUCinf of ABBV-990. | Up to approximately 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 247995 | Grayslake | Illinois | 60030 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo for ABBV-990 | Drug | Oral Tablet |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |