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

Phase 1TerminatedNCT05475821

AbbVie24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Up to approximately 30 days

Maximum Observed Plasma Concentration (Cmax) of ABBV-990

Cmax of ABBV-990.