Clinical trial NCT05475821: Study to Assess Adverse Events and How Oral ABBV-990 Moves Through the Body of Adult Healthy Participants
Official title: A First in Human, Single Ascending Dose Study for the Assessment of Pharmacokinetics, Safety and Tolerability of ABBV-990 in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
CoronaVirus Disease-2019 (COVID-19)
ABBV-990
SARS-CoV-2
Severe Acute Respiratory Syndrome Coronavirus-2
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-07-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to approximately 30 days
measure: Maximum Observed Plasma Concentration (Cmax) of ABBV-990
timeFrame: Up to approximately 5 days
measure: Time to Cmax (Tmax) of ABBV-990
timeFrame: Up to approximately 5 days
measure: Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-990
timeFrame: Up to approximately 5 days
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-990
timeFrame: Up to approximately 5 days
measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-990
timeFrame: Up to approximately 5 days
measure: AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990
timeFrame: Up to approximately 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 247995
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: