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

NCT05475821 | Terminated Phase 1 FDA Drug

• 1 other identifier: M23-661
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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.

  Up to approximately 30 days

• Maximum Observed Plasma Concentration (Cmax) of ABBV-990

  Cmax of ABBV-990.

  Up to approximately 5 days

• Time to Cmax (Tmax) of ABBV-990

  Tmax of ABBV-990.

  Up to approximately 5 days

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

  Apparent terminal phase elimination rate constant of ABBV-990.

  Up to approximately 5 days

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

  Terminal phase elimination half-life of ABBV-990.

  Up to approximately 5 days

• 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.

  Up to approximately 5 days

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

  AUCinf of ABBV-990.

  Up to approximately 5 days

Study Arms (5)

Group 1

EXPERIMENTAL

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

Drug: ABBV-990; Drug: Placebo for ABBV-990

Group 2

EXPERIMENTAL

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

Drug: ABBV-990; Drug: Placebo for ABBV-990

Group 3

EXPERIMENTAL

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

Drug: ABBV-990; Drug: Placebo for ABBV-990

Group 4

EXPERIMENTAL

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

Drug: ABBV-990; Drug: Placebo for ABBV-990

Group 5

EXPERIMENTAL

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

Drug: ABBV-990; Drug: Placebo for ABBV-990

Interventions

ABBV-990 DRUG

Oral Tablet

Group 1; Group 2; Group 3; Group 4; Group 5

Placebo for ABBV-990 DRUG

Oral Tablet

Group 1; Group 2; Group 3; Group 4; Group 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 247995

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: July 25, 2022
• Primary Completion: September 26, 2022
• Study Completion: September 26, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)