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

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 Overview

• Status: Terminated
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ABBV-990; Drug: Placebo for ABBV-990

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 247995

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: TRIPLE

Number of Arms

5

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 25, 2022
• Primary Completion (ACTUAL): September 26, 2022
• Study Completion (ACTUAL): September 26, 2022

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (ACTUAL): July 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Healthy Volunteers; Severe Acute Respiratory Syndrome Coronavirus-2; CoronaVirus Disease-2019 (COVID-19); ABBV-990
• Other Study ID Numbers: M23-661

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes