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
Overview
- Phase
- Phase 1
- Intervention
- ABBV-990
- Conditions
- Healthy Volunteers
- Sponsor
- AbbVie
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m
- •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.
Arms & Interventions
Group 1
Participants will receive ABBV-990 Dose A or matching placebo.
Intervention: ABBV-990
Group 1
Participants will receive ABBV-990 Dose A or matching placebo.
Intervention: Placebo for ABBV-990
Group 2
Participants will receive ABBV-990 Dose B or matching placebo.
Intervention: ABBV-990
Group 2
Participants will receive ABBV-990 Dose B or matching placebo.
Intervention: Placebo for ABBV-990
Group 3
Participants will receive ABBV-990 Dose C or matching placebo.
Intervention: ABBV-990
Group 3
Participants will receive ABBV-990 Dose C or matching placebo.
Intervention: Placebo for ABBV-990
Group 4
Participants will receive ABBV-990 Dose D or matching placebo.
Intervention: ABBV-990
Group 4
Participants will receive ABBV-990 Dose D or matching placebo.
Intervention: Placebo for ABBV-990
Group 5
Participants will receive ABBV-990 Dose E or matching placebo.
Intervention: ABBV-990
Group 5
Participants will receive ABBV-990 Dose E or matching placebo.
Intervention: Placebo for ABBV-990
Outcomes
Primary Outcomes
AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990
Time Frame: Up to approximately 5 days
AUCinf of ABBV-990.
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: 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.
Maximum Observed Plasma Concentration (Cmax) of ABBV-990
Time Frame: Up to approximately 5 days
Cmax of ABBV-990.
Time to Cmax (Tmax) of ABBV-990
Time Frame: Up to approximately 5 days
Tmax of ABBV-990.
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-990
Time Frame: Up to approximately 5 days
Apparent terminal phase elimination rate constant of ABBV-990.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-990
Time Frame: Up to approximately 5 days
Terminal phase elimination half-life of ABBV-990.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-990
Time Frame: Up to approximately 5 days
AUCt of ABBV-990.