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
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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TERMINATED
PHASE1
24 participants
INTERVENTIONAL
2022-07-25
2022-09-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
TRIPLE
Study Groups
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Group 1
Participants will receive ABBV-990 Dose A or matching placebo.
ABBV-990
Oral Tablet
Placebo for ABBV-990
Oral Tablet
Group 2
Participants will receive ABBV-990 Dose B or matching placebo.
ABBV-990
Oral Tablet
Placebo for ABBV-990
Oral Tablet
Group 3
Participants will receive ABBV-990 Dose C or matching placebo.
ABBV-990
Oral Tablet
Placebo for ABBV-990
Oral Tablet
Group 4
Participants will receive ABBV-990 Dose D or matching placebo.
ABBV-990
Oral Tablet
Placebo for ABBV-990
Oral Tablet
Group 5
Participants will receive ABBV-990 Dose E or matching placebo.
ABBV-990
Oral Tablet
Placebo for ABBV-990
Oral Tablet
Interventions
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ABBV-990
Oral Tablet
Placebo for ABBV-990
Oral Tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Acpru /Id# 247995
Grayslake, Illinois, United States
Countries
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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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