Group 4 for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acpru /Id# 247995, Grayslake, IL
Healthy Subjects (HS)
ABBV-990 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

7 Primary · 0 Secondary · Reporting Duration: Up to approximately 30 days

Day 30
Number of Participants Experiencing Adverse Events (AEs)
Day 5
AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990
Apparent Terminal Phase Elimination Rate Constant (β) 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
Maximum Observed Plasma Concentration (Cmax) of ABBV-990
Terminal Phase Elimination Half-Life (t1/2) of ABBV-990
Time to Cmax (Tmax) of ABBV-990

Trial Safety

Safety Progress

1 of 3

Trial Design

5 Treatment Groups

Group 4
1 of 5
Group 5
1 of 5
Group 3
1 of 5
Group 2
1 of 5
Group 1
1 of 5
Experimental Treatment

40 Total Participants · 5 Treatment Groups

Primary Treatment: Group 4 · Has Placebo Group · Phase 1

Group 4Experimental Group · 2 Interventions: Placebo for ABBV-990, ABBV-990 · Intervention Types: Drug, Drug
Group 5Experimental Group · 2 Interventions: Placebo for ABBV-990, ABBV-990 · Intervention Types: Drug, Drug
Group 3Experimental Group · 2 Interventions: Placebo for ABBV-990, ABBV-990 · Intervention Types: Drug, Drug
Group 2Experimental Group · 2 Interventions: Placebo for ABBV-990, ABBV-990 · Intervention Types: Drug, Drug
Group 1Experimental Group · 2 Interventions: Placebo for ABBV-990, ABBV-990 · Intervention Types: Drug, Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 30 days
Closest Location: Acpru /Id# 247995 · Grayslake, IL
N/AFirst Recorded Clinical Trial
1 TrialsResearching Healthy Subjects (HS)
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
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).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.