Study to Assess Adverse Events and How Oral ABBV-990 Moves Through the Body of Adult Healthy Participants

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A First in Human, Single Ascending Dose Study for the Assessment of Pharmacokinetics, Safety and Tolerability of ABBV-990 in Healthy Male and Female Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: ABBV-990
* Drug: Placebo for ABBV-990


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2. Laboratory values meet the protocol-specified criteria. A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG). In the opinion of the investigator, participant is a suitable candidate for enrollment in the study. Exclusion Criteria: Have any clinically significant ECG abnormalities. History of any clinically significant sensitivity or allergy to any medication or food. Known active SARS-CoV-2 infection at screening and upon initial confinement. History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug. Currently enrolled in another interventional clinical study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Participants will receive ABBV-990 Dose A or matching placebo. | Drug: ABBV-990<br>* Oral Tablet<br>Drug: Placebo for ABBV-990<br>* Oral Tablet<br>|
| Experimental: Group 2<br>Participants will receive ABBV-990 Dose B or matching placebo. | Drug: ABBV-990<br>* Oral Tablet<br>Drug: Placebo for ABBV-990<br>* Oral Tablet<br>|
| Experimental: Group 3<br>Participants will receive ABBV-990 Dose C or matching placebo. | Drug: ABBV-990<br>* Oral Tablet<br>Drug: Placebo for ABBV-990<br>* Oral Tablet<br>|
| Experimental: Group 4<br>Participants will receive ABBV-990 Dose D or matching placebo. | Drug: ABBV-990<br>* Oral Tablet<br>Drug: Placebo for ABBV-990<br>* Oral Tablet<br>|
| Experimental: Group 5<br>Participants will receive ABBV-990 Dose E or matching placebo. | Drug: ABBV-990<br>* Oral Tablet<br>Drug: Placebo for ABBV-990<br>* Oral Tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers, CoronaVirus Disease-2019 (COVID-19), ABBV-990, SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus-2