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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-382 Dose A | Experimental | 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. |
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| ABBV-382 Dose A Placebo | Placebo Comparator | 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. |
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| ABBV-382 Dose B | Experimental | 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. |
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| ABBV-382 Dose B Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-382 | Drug | Subcutaneous (SC) Injection |
| |
| ABBV-382 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | 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. | Up to Approximately Day 140 |
| Maximum Observed Serum Concentration (Cmax) of ABBV-382 | Maximum observed serum concentration (Cmax) of ABBV-382. | Up to Day 112 |
| Time to Cmax (Tmax) of ABBV-382 | Time to Cmax (Tmax) of ABBV-382. | Up to Day 112 |
| Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-382 | Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-382. | Up to Day 112 |
| Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-382 | AUC from time 0 to infinite time (AUCinf) of ABBV-382. | Up to Day 112 |
| Terminal Phase Elimination Rate Constant (β) of ABBV-382 | Terminal phase elimination rate constant of ABBV-382. | Up to Day 112 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 | Terminal phase elimination half-life of ABBV-382. |
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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:
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital /ID# 264785 | Shanghai | Shanghai Municipality | 200031 | China |
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| Drug |
Intravenous (IV) Infusion |
|
| Placebo for ABBV-382 | Drug | IV Infusion |
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| Placebo for ABBV-382 | Drug | SC Injection |
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| Up to Day 112 |
| Anti-Drug Antibody (ADA) of ABBV-382 | Confirmed Positive ADA Results. | Up to Day 112 |