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This is a study to assess the pharmacokinetics, safety and tolerability of multiple ascending oral doses of ABBV-553 in healthy volunteers and the pharmacokinetics, safety, tolerability and efficacy of multiple ascending oral doses of ABBV-553 in participants with psoriasis under non-fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Participants, who are healthy volunteers, receiving ABBV-553 dose A or placebo |
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| Arm B | Experimental | Participants, who are healthy volunteers, receiving ABBV-553 dose B or placebo |
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| Arm C | Experimental | Participants, who are healthy volunteers, receiving ABBV-553 dose C or placebo |
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| Arm D | Experimental | Participants, who are healthy volunteers, receiving ABBV-553 dose D or placebo |
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| Arm E | Experimental | Participants with psoriasis receiving ABBV-553 dose B or placebo |
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| Arm F | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-553 | Drug | It is administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Substudy 1: Maximum observed plasma concentration (Cmax) of ABBV-553 | Maximum observed plasma concentration (Cmax) of ABBV-553 | Day 1 |
| Substudy 2: Maximum observed plasma concentration (Cmax) of ABBV-553 | Maximum observed plasma concentration (Cmax) of ABBV-553 | Day 1 |
| Substudy 1: Time to Cmax (peak time, Tmax) | Time to Cmax (peak time, Tmax) | Day 1 |
| Substudy 2: Time to Cmax (peak time, Tmax) | Time to Cmax (peak time, Tmax) | Day 1 |
| Substudy 1: Area under the concentration time curve (AUC) from time zero to 24 hours after dosing | Area under the concentration time curve (AUC) from time zero to 24 hours after dosing | Day 1 |
| Substudy 2: Area under the concentration time curve (AUC) from time zero to 24 hours after dosing | Area under the concentration time curve (AUC) from time zero to 24 hours after dosing | Day 1 |
| Substudy 1: Observed plasma concentration at the end of the dosing interval (Ctrough) | Observed plasma concentration at the end of the dosing interval (Ctrough) | Day 7 and Day 14 |
| Substudy 2: Observed plasma concentration at the end of the dosing interval (Ctrough) |
| Measure | Description | Time Frame |
|---|---|---|
| Substudy 2: Psoriasis Area and Severity Index (PASI) | Percent improvement in PASI from Baseline | Day 28 |
| Substudy 2: Self-Assessment of Psoriasis Symptoms (SAPS) scores | Psoriasis subjects participating in Substudy 2 will complete the questionnaire at the designated clinic. |
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Inclusion Criteria: - Male or female and between 18 and 55 years of age, inclusive, for Substudy 1, OR between 18 and 75 years of age, inclusive, for Substudy 2.
If female, participant must be of non-child bearing potential defined as either:
a. Postmenopausal: Age > 55 years with no menses for 12 or more months without an alternative medical cause. Postmenopausal: Age <= 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle stimulating hormone (FSH) level >= 40 IU/L (OR) b. Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
Non-postmenopausal females must have a negative urine pregnancy test result at Screening, and a negative serum pregnancy test result on Day -2 or Day -1.
Male participants who are sexually active with women of child bearing potential (WOCBP), even if the male participant has undergone a successful vasectomy, must agree to use condoms from Day 1 through at least 30 days after the last dose of study drug, and male participant agrees not to donate sperm at least 30 days after the last dose of study drug.
Body Mass Index (BMI) >= 18.0 to <= 29.9 kg/m2 after rounding to the tenths decimal for Substudy 1 OR BMI >= 18.0 to <= 34.9 kg/m2 after rounding to the tenths decimal for Substudy 2. BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m).
In the opinion of the Investigator, that the participant is in 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).
Must voluntarily sign and date each informed consent form, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures and be willing to comply with the requirements of this study protocol.
Additional criteria for Substudy 2:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials LLC /ID# 164101 | Anaheim | California | 92801 | United States | ||
| Providence Clinical Research /ID# 163867 |
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Participants with psoriasis receiving ABBV-553 dose C or placebo
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| Placebo | Drug | It is administered orally. |
|
Observed plasma concentration at the end of the dosing interval (Ctrough) |
| Day 28 |
| Substudy 1: Apparent clearance (CL/F) | Apparent clearance (CL/F) | Day 14 |
| Substudy 2: Apparent clearance (CL/F) | Apparent clearance (CL/F) | Day 28 |
| Substudy 1: Volume of distribution (Vβ/F) | Volume of distribution (Vβ/F) | Day 14 |
| Substudy 2: Volume of distribution (Vβ/F) | Volume of distribution (Vβ/F) | Day 28 |
| Substudy 1: Fraction excreted unchanged in urine (fe) | Fraction excreted unchanged in urine (fe) | Day 14 |
| Substudy 1: Apparent renal clearance (CLR) | Apparent renal clearance (CLR) | Day 14 |
| Day 28 |
| Toluca |
| California |
| 91606 |
| United States |
| Progressive Medical Research /ID# 163868 | Port Orange | Florida | 32127 | United States |
| Abbvie Clinical Pharmacology Research Unit /ID# 163866 | Grayslake | Illinois | 60030 | United States |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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