Phase 1 BA Study, Single Center With Healthy Volunteers

Study Overview
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Brief Summary
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Single dose in healthy volunteers to assess bioavailability (amount of study drug in the system) between different formulations of ABT-874.

Conditions
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Healthy

Intervention / Treatment
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* Drug: ABT-874


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be healthy Exclusion Criteria: Subjects who are not healthy, enrolled in another study, or who have received ABT-874 previously.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regimen A<br>One 100 mg ABT-874 (pre-filled syringe liquid formulation from the 6000 L process) injected subcutaneously in the abdominal region at a 45 degree angle | Drug: ABT-874<br>* See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.<br>|
| Experimental: Regimen B<br>One 100 mg ABT-874 (pre-filled syringe liquid formulation from the 6000 L process) injected IV in an arm vein | Drug: ABT-874<br>* See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.<br>|
| Experimental: Regimen C<br>One 100 mg ABT 874 (reconstituted lyophilized powder from the 3000 L process) injected subcutaneously in the abdominal region at a 45 degree angle | Drug: ABT-874<br>* See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.<br>|
| Experimental: Regimen D<br>One 100 mg ABT-874 (reconstituted lyophilized powder from the 1000 L process) injected subcutaneously in the abdominal region at a 45 degree angle | Drug: ABT-874<br>* See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.<br>|
| Experimental: Regimen E<br>700 mg ABT-874 (reconstituted lyophilized powder from the 3000 L process) in 100 mL 5% dextrose solution IV infusion in an arm vein | Drug: ABT-874<br>* See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability following single dose |  | Hours: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 1008, 1344 for Regimens A, C, D and additional hours 4 & 8 for Regimen B and hours 0.5 and 6 hours for Regimen E | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study |  | Through Day 85 (and / or 45 days after study drug stoppped) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Label, Healthy Volunteers