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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05475821
• Other study ID #: M23-661
• Status: Terminated
• Phase: Phase 1
• Start date: July 25, 2022
• Est. completion date: September 26, 2022

Study information

• Verified date: October 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: September 26, 2022
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ABBV-990
Oral Tablet
• Placebo for ABBV-990
Oral Tablet

Locations

Country	Name	City	State
United States	Acpru /Id# 247995	Grayslake	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum Observed Plasma Concentration (Cmax) of ABBV-990	Cmax of ABBV-990.	Up to approximately 5 days
Primary	Time to Cmax (Tmax) of ABBV-990	Tmax of ABBV-990.	Up to approximately 5 days
Primary	Apparent Terminal Phase Elimination Rate Constant (ß) of ABBV-990	Apparent terminal phase elimination rate constant of ABBV-990.	Up to approximately 5 days
Primary	Terminal Phase Elimination Half-Life (t1/2) of ABBV-990	Terminal phase elimination half-life of ABBV-990.	Up to approximately 5 days
Primary	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
Primary	AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990	AUCinf of ABBV-990.	Up to approximately 5 days

External Links

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