Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-382
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.
Interventions
DRUGABBV-382
Subcutaneous (SC) Injection
IV Infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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. * Females of childbearing potential must agree to avoid pregnancy while taking study drug(s) from Study Day 1 through the end of the study (Day 140) plus an additional 90 days. * Females of childbearing potential must use a contraceptive method that is highly effective (with a failure rate of \< 1% per year, when used consistently and correctly). * Male subjects who are sexually active with a female partner of childbearing potential must agree to use condoms, from Study Day 1 through the end of study (Day 140) plus an additional 90 days, even if the male subject has undergone a successful vasectomy. * Male subjects who are not considering fathering a child or donating sperm during the study from Study Day 1 through the end of the study (Day 140) plus an additional 90 days. * Laboratory values meeting those specified in the protocol. * A condition of generally good health based on the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG). * In the opinion of the investigator, this participant is a suitable candidate for enrollment in the study.
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-382. * 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. * Participant requires any over-the-counter and/or prescription medication, vitamins and/or herbal supplements, with the exception of contraceptives or hormonal replacement therapies for females, on a regular basis. * Participant uses any medications, vitamins and/or herbal supplements, with the exception of contraceptives or hormonal replacement therapies for females, within the 2-week period prior to study drug administration. * Receipt of any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration, with the exception of parenteral hormonal contraceptives or hormonal replacement therapies for females * Exposure to antibody-based immunotherapy or previous enrollment in antibody-based immunotherapy clinical trials within a period defined by 5 half-lives prior to the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | 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 | Up to Day 112 | Maximum observed serum concentration (Cmax) of ABBV-382. |
| Time to Cmax (Tmax) of ABBV-382 | 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 | 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 | Up to Day 112 | AUC from time 0 to infinite time (AUCinf) of ABBV-382. |
| Terminal Phase Elimination Rate Constant (β) of ABBV-382 | Up to Day 112 | Terminal phase elimination rate constant of ABBV-382. |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 | Up to Day 112 | Terminal phase elimination half-life of ABBV-382. |
| Anti-Drug Antibody (ADA) of ABBV-382 | Up to Day 112 | Confirmed Positive ADA Results. |
Countries
China
Outcome results
None listed