A Randomized, Single-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ABBV-382 in Healthy Adult Chinese Volunteers
Overview
- Phase
- Phase 1
- Intervention
- ABBV-382
- Conditions
- Healthy Volunteer
- Sponsor
- AbbVie
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number of Participants with Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
The main objectives of this study are to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single subcutaneous (SC) and intravenous (IV) doses of ABBV-382 in healthy adult Chinese volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body Mass Index (BMI) is \>= 18.0 to \<= 27.9 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •Females, Non-Childbearing Potential:
- •Premenopausal female with permanent sterility or infertility due to one of following:
- •Permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
- •Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis OR
- •Postmenopausal, defined as age \<= 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level \>= 30 IU/L.
- •Females of Childbearing Potential:
- •If a female does not meet the definition of a female of nonchildbearing potential above, she would be considered a female of childbearing potential.
- •Females of childbearing potential must not be pregnant or breastfeeding.
- •Females of childbearing potential consent to abide by contraception requirements.
Exclusion Criteria
- •History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- •History of any clinically significant sensitivity or allergy to any medication or food, including no history of allergic reaction or anaphylaxis to therapeutic proteins, vaccines, or other parenteral treatments.
- •History of hereditary fructose intolerance
- •Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
- •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.
- •Donated blood (including plasmapheresis), lost \>= 550 mL blood volume, or received a transfusion of any blood product within 3 months prior to study drug administration.
- •Has been previously enrolled in this study.
- •Participant has been treated with any investigational drug within 3 months or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
- •Participant has been treated with any anti-α4β7 integrin monoclonal antibody (Ab) or had prior exposure to ABBV-
- •Participant has received any live vaccine within 4 weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 4 months (120 days) after the last dose of study drug.
Arms & Interventions
ABBV-382 Dose A
Participant will receive a single dose of ABBV-382 Dose A on Day 1 and will be confined to the study site and supervised for approximately 9 days. Participants will be followed-up for approximately 20 weeks.
Intervention: ABBV-382
ABBV-382 Dose A Placebo
Participant will receive a single dose of ABBV-382 Dose A placebo on Day 1 and will be confined to the study site and supervised for approximately 9 days. Participants will be followed-up for approximately 20 weeks.
Intervention: Placebo for ABBV-382
ABBV-382 Dose B
Participant will receive a single dose of ABBV-382 Dose B on Day 1 and will be confined to the study site and supervised for approximately 5 days. Participants will be followed-up for approximately 20 weeks.
Intervention: ABBV-382
ABBV-382 Dose B Placebo
Participant will receive a single dose of ABBV-382 Dose B placebo on Day 1 and will be confined to the study site and supervised for approximately 5 days. Participants will be followed-up for approximately 20 weeks.
Intervention: Placebo for ABBV-382
Outcomes
Primary Outcomes
Number of Participants with Adverse Events (AEs)
Time Frame: Up to Approximately Day 140
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Maximum Observed Serum Concentration (Cmax) of ABBV-382
Time Frame: Up to Day 112
Maximum observed serum concentration (Cmax) of ABBV-382.
Time to Cmax (Tmax) of ABBV-382
Time Frame: Up to Day 112
Time to Cmax (Tmax) of ABBV-382.
Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-382
Time Frame: Up to Day 112
Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-382.
Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-382
Time Frame: Up to Day 112
AUC from time 0 to infinite time (AUCinf) of ABBV-382.
Terminal Phase Elimination Rate Constant (β) of ABBV-382
Time Frame: Up to Day 112
Terminal phase elimination rate constant of ABBV-382.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-382
Time Frame: Up to Day 112
Terminal phase elimination half-life of ABBV-382.
Anti-Drug Antibody (ADA) of ABBV-382
Time Frame: Up to Day 112
Confirmed Positive ADA Results.