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

• Sponsor: AbbVie (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05475821
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 5
• Anticipated Duration (Months): 2.3
• Patients Per Site Per Month: 17.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: ABBV-990; Drug: Placebo for ABBV-990	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: A First in Human, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-990 in Healthy Subjects
• Actual Study Start Date: Jul 25, 2022
• Anticipated Primary Completion Date: Oct 3, 2022
• Anticipated Study Completion Date: Oct 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Participants will receive ABBV-990 Dose A or matching placebo.	Drug: ABBV-990; Oral Tablet; Drug: Placebo for ABBV-990; Oral Tablet
Experimental: Group 2 Participants will receive ABBV-990 Dose B or matching placebo.	Drug: ABBV-990; Oral Tablet; Drug: Placebo for ABBV-990; Oral Tablet
Experimental: Group 3 Participants will receive ABBV-990 Dose C or matching placebo.	Drug: ABBV-990; Oral Tablet; Drug: Placebo for ABBV-990; Oral Tablet
Experimental: Group 4 Participants will receive ABBV-990 Dose D or matching placebo.	Drug: ABBV-990; Oral Tablet; Drug: Placebo for ABBV-990; Oral Tablet
Experimental: Group 5 Participants will receive ABBV-990 Dose E or matching placebo.	Drug: ABBV-990; Oral Tablet; Drug: Placebo for ABBV-990; Oral Tablet

Outcome Measures

Primary Outcome Measures

1. Number of Participants Experiencing Adverse Events (AEs) [Up to approximately 30 days]

   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.

2. Maximum Observed Plasma Concentration (Cmax) of ABBV-990 [Up to approximately 5 days]

   Cmax of ABBV-990.

3. Time to Cmax (Tmax) of ABBV-990 [Up to approximately 5 days]

   Tmax of ABBV-990.

4. Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-990 [Up to approximately 5 days]

   Apparent terminal phase elimination rate constant of ABBV-990.

5. Terminal Phase Elimination Half-Life (t1/2) of ABBV-990 [Up to approximately 5 days]

   Terminal phase elimination half-life of ABBV-990.

6. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-990 [Up to approximately 5 days]

   AUCt of ABBV-990.

7. AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990 [Up to approximately 5 days]

   AUCinf of ABBV-990.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acpru /Id# 247995	Grayslake	Illinois	United States	60030

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT05475821
• Other Study ID Numbers: M23-661
• First Posted: Jul 27, 2022
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by AbbVie: Healthy Volunteers; CoronaVirus Disease-2019 (COVID-19); ABBV-990; SARS-CoV-2; Severe Acute Respiratory Syndrome Coronavirus-2

Study Results

No Results Posted as of Jul 27, 2022