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

AbbVie

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05475821

M23-661

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

24 participants in 5 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABBV-990

Drug: ABBV-990

Group 2

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABBV-990

Drug: ABBV-990

Group 3

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABBV-990

Drug: ABBV-990

Group 4

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABBV-990

Drug: ABBV-990

Group 5

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABBV-990

Drug: ABBV-990