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The objective of this study is to assess the safety, tolerability, pharmacokinetics and immunogenicity of either single ascending intravenous (IV) doses of ABBV-243 or single ascending subcutaneous (SC) doses of ABBV-243 in healthy adult participants (Part 1), and a single intravenous (IV) dose in healthy Asian adult volunteers (Part 2
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ABBV-243 or Placebo | Experimental | Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1 |
|
| Group 2: ABBV-243 or Placebo | Experimental | Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1 |
|
| Group 3: ABBV-243 or Placebo | Experimental | Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1 |
|
| Group 4: ABBV-243 or Placebo | Experimental | Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1 |
|
| Group 5: ABBV-243 or Placebo | Experimental | Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-243 | Drug | Intravenous (IV) Infusion |
|
| 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 subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to Day 204 |
| Maximum Observed Serum Concentration (Cmax) of ABBV-243 | Maximum observed serum concentration (Cmax) of ABBV-243 | Up to Day 204 |
| Time to Cmax (Tmax) of ABBV-243 | Time to Cmax (Tmax) of ABBV-243 | Up to Day 204 |
| Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-243 | Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-243 | Up to Day 204 |
| Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-243 | AUC from time 0 to infinite time (AUCinf) of ABBV-243 | Up to Day 204 |
| Terminal Phase Elimination Rate Constant (β) of ABBV-243 | Terminal phase elimination rate constant of ABBV-243 | Up to Day 204 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-243 | Terminal phase elimination half-life of ABBV-243 |
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Inclusion Criteria:
Individuals between 18 and 60 years of age inclusive at the time of Screening.
BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth's decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
Females, Non-Childbearing Potential are eligible as defined by meeting the following criteria:
Females, Childbearing Potential are defined as all other females who do not meet the above criteria and must adhere to the following:
Part 2 only:
Healthy Japanese and Han Chinese male or female; between 18 and 60 years of age, inclusive at the time of Screening.
- Han Chinese participants must be first- or second-generation Han Chinese of full Chinese parentage. First-generation participants are defined as those born in China to two parents and four grandparents also born in China of full Chinese descent. Second-generation participants are defined as those born outside of China to two parents and four grandparents born in China of full Chinese descent.
OR
- Japanese participants must be first- or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation subjects born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 279789 | Recruiting | Grayslake | Illinois | 60030 | United States |
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| Group 6: ABBV-243 or Placebo | Experimental | Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1 |
|
| Group 7: ABBV-243 or Placebo | Experimental | Han Chinese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1 |
|
| Group 8: ABBV-243 or Placebo | Experimental | Japanese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1 |
|
| Placebo | Drug | Intravenous (IV) Infusion |
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| ABBV-243 | Drug | Subcutaneous (SC) Injection |
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| Placebo | Drug | Subcutaneous (SC) Injection |
|
| Up to Day 204 |
| Anti-Drug Antibody (ADA) of ABBV-243 | Confirmed Positive ADA Results. | Up to Day 204 |