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

NCT ID: NCT05475821

Last Updated: 2022-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-25

Study Completion Date

2022-09-26

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1

Participants will receive ABBV-990 Dose A or matching placebo.

Group Type EXPERIMENTAL

ABBV-990

Intervention Type DRUG

Oral Tablet

Placebo for ABBV-990

Intervention Type DRUG

Oral Tablet

Group 2

Participants will receive ABBV-990 Dose B or matching placebo.

Group Type EXPERIMENTAL

ABBV-990

Intervention Type DRUG

Oral Tablet

Placebo for ABBV-990

Intervention Type DRUG

Oral Tablet

Group 3

Participants will receive ABBV-990 Dose C or matching placebo.

Group Type EXPERIMENTAL

ABBV-990

Intervention Type DRUG

Oral Tablet

Placebo for ABBV-990

Intervention Type DRUG

Oral Tablet

Group 4

Participants will receive ABBV-990 Dose D or matching placebo.

Group Type EXPERIMENTAL

ABBV-990

Intervention Type DRUG

Oral Tablet

Placebo for ABBV-990

Intervention Type DRUG

Oral Tablet

Group 5

Participants will receive ABBV-990 Dose E or matching placebo.

Group Type EXPERIMENTAL

ABBV-990

Intervention Type DRUG

Oral Tablet

Placebo for ABBV-990

Intervention Type DRUG

Oral Tablet

Interventions

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ABBV-990

Oral Tablet

Intervention Type DRUG

Placebo for ABBV-990

Oral Tablet

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Acpru /Id# 247995

Grayslake, Illinois, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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M23-661

Identifier Type: -

Identifier Source: org_study_id

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