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

Phase 1

Terminated

• Conditions: Healthy Volunteers
• Interventions: Drug: ABBV-990; Drug: Placebo for ABBV-990

• Registration Number: NCT05475821
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-25
• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-27
• Primary Completion: 2022-09-26
• Study Completion: 2022-09-26
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 1	ABBV-990	Participants will receive ABBV-990 Dose A or matching placebo.
Group 1	Placebo for ABBV-990	Participants will receive ABBV-990 Dose A or matching placebo.
Group 2	Placebo for ABBV-990	Participants will receive ABBV-990 Dose B or matching placebo.
Group 3	ABBV-990	Participants will receive ABBV-990 Dose C or matching placebo.
Group 3	Placebo for ABBV-990	Participants will receive ABBV-990 Dose C or matching placebo.
Group 4	Placebo for ABBV-990	Participants will receive ABBV-990 Dose D or matching placebo.
Group 5	Placebo for ABBV-990	Participants will receive ABBV-990 Dose E or matching placebo.
Group 2	ABBV-990	Participants will receive ABBV-990 Dose B or matching placebo.
Group 4	ABBV-990	Participants will receive ABBV-990 Dose D or matching placebo.
Group 5	ABBV-990	Participants will receive ABBV-990 Dose E or matching placebo.

Primary Outcome Measures

Name	Time	Method
AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990	Up to approximately 5 days	AUCinf of ABBV-990.
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.

Trial Locations

Locations (1)

Acpru /Id# 247995; 🇺🇸 Grayslake, Illinois, United States