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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05475821

Enrollment

Registered

2022-07-27

Start date

2022-07-25

Completion date

2022-09-26

Last updated

2022-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers, CoronaVirus Disease-2019 (COVID-19), ABBV-990, SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus-2

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.

Interventions

DRUGABBV-990

Oral Tablet

DRUGPlacebo for ABBV-990

Oral Tablet

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Experiencing Adverse Events (AEs)	Up to approximately 30 days	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.
Maximum Observed Plasma Concentration (Cmax) of ABBV-990	Up to approximately 5 days	Cmax of ABBV-990.
Time to Cmax (Tmax) of ABBV-990	Up to approximately 5 days	Tmax of ABBV-990.
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-990	Up to approximately 5 days	Apparent terminal phase elimination rate constant of ABBV-990.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-990	Up to approximately 5 days	Terminal phase elimination half-life of ABBV-990.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-990	Up to approximately 5 days	AUCt of ABBV-990.
AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990	Up to approximately 5 days	AUCinf of ABBV-990.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026