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TerminatedNCT05475821Updated Oct 27, 2022

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

A Phase 1 interventional study of ABBV-990 and Placebo for ABBV-990 in Healthy Volunteers, sponsored by AbbVie. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-27.

Sponsored by AbbVie · Phase 1, Interventional, and Basic science

Why this study was terminated
Company decision: re-evaluation of risk vs benefit (based on animal data)

From the registry’s dates

  • Primary completion was Sep 2022, 4 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers

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Keywords

  • Healthy Volunteers
  • CoronaVirus Disease-2019 (COVID-19)
  • ABBV-990
  • SARS-CoV-2
  • Severe Acute Respiratory Syndrome Coronavirus-2
03

In context

COVID-19

7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 24 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

AbbVie is the lead sponsor of 969 studies on the registry; 134 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Group 1

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

    Drug: ABBV-990 · Drug: Placebo for ABBV-990

  • Experimental
    Group 2

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

    Drug: ABBV-990 · Drug: Placebo for ABBV-990

  • Experimental
    Group 3

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

    Drug: ABBV-990 · Drug: Placebo for ABBV-990

  • Experimental
    Group 4

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

    Drug: ABBV-990 · Drug: Placebo for ABBV-990

  • Experimental
    Group 5

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

    Drug: ABBV-990 · Drug: Placebo for ABBV-990

Interventions

  • DrugABBV-990

    Oral Tablet

  • DrugPlacebo for ABBV-990

    Oral Tablet

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 30 days

  2. Maximum Observed Plasma Concentration (Cmax) of ABBV-990

    Cmax of ABBV-990.

    Time frame: Up to approximately 5 days

  3. Time to Cmax (Tmax) of ABBV-990

    Tmax of ABBV-990.

    Time frame: Up to approximately 5 days

  4. Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-990

    Apparent terminal phase elimination rate constant of ABBV-990.

    Time frame: Up to approximately 5 days

  5. Terminal Phase Elimination Half-Life (t1/2) of ABBV-990

    Terminal phase elimination half-life of ABBV-990.

    Time frame: Up to approximately 5 days

  6. 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.

    Time frame: Up to approximately 5 days

  7. AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990

    AUCinf of ABBV-990.

    Time frame: Up to approximately 5 days

07

Study locations

1 site
  • Acpru /Id# 247995
    Grayslake, Illinois 60030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2022 to primary completion in Sep 2022, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2022
First posted
Jul 27, 2022
StartActual
Jul 25, 2022
Primary completionActual
Sep 26, 2022
CompletionActual
Sep 26, 2022
Last update
Oct 27, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05475821
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jul 27, 2022
Start date
Jul 25, 2022
Primary completion
Sep 26, 2022
Completion
Sep 26, 2022
Last update
Oct 27, 2022

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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