A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian Participants
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1, ABBV-141 (Intravenous [IV]) Western participants will receive a single IV dose of ABBV-141. |
Drug: ABBV-141
Infusion; intravenous (IV)
|
| Placebo Comparator: Part 1, Placebo for ABBV-141 (IV) Western participants will receive a single IV dose of placebo for ABBV-141. |
Drug: Placebo for ABBV-141
Infusion; IV
|
| Experimental: Part 1, ABBV-141 (subcutaneous [SC]) Western participants will receive a single SC dose of ABBV-141. |
Drug: ABBV-141
Injection; subcutaneous (SC)
|
| Placebo Comparator: Part 1, Placebo for ABBV-141 (SC) Western participants will receive a single SC dose of placebo for ABBV-141. |
Drug: Placebo for ABBV-141
Injection; SC
|
| Experimental: Part 2, ABBV-141 (IV) Asian participants will receive a single IV dose of ABBV-141. |
Drug: ABBV-141
Infusion; intravenous (IV)
|
| Placebo Comparator: Part 2, Placebo for ABBV-141 (IV) Asian participants will receive a single IV dose of placebo for ABBV-141. |
Drug: Placebo for ABBV-141
Infusion; IV
|
| Experimental: Part 2, ABBV-141 (SC) Asian participants will receive a single SC dose of ABBV-141. |
Drug: ABBV-141
Injection; subcutaneous (SC)
|
| Placebo Comparator: Part 2, Placebo for ABBV-141 (SC) Asian participants will receive a single SC dose of placebo for ABBV-141. |
Drug: Placebo for ABBV-141
Injection; SC
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of ABBV-141 [Up to Day 85]
Cmax of ABBV-141 will be assessed.
- Time to Cmax (Tmax) of ABBV-141 [Up to Day 85]
Tmax of ABBV-141 will be assessed.
- Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt) [Up to Day 85]
AUCt of ABBV-141 will be determined.
- AUC of ABBV-141 from Time 0 to Infinity (AUCinf) [Up to Day 85]
AUCinf of ABBV-141 will be assessed.
- Terminal Phase Elimination Rate Constant (β) of ABBV-141 [Up to Day 85]
Terminal phase elimination rate constant (β) of ABBV-141 will be assessed.
- Terminal Phase Elimination Half-life (t1/2) of ABBV-141 [Up to Day 85]
Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed.
- Dose Normalized Cmax of ABBV-141 [Up to Day 85]
Dose normalized Cmax of ABBV-141 will be assessed.
- Dose Normalized AUC of ABBV-141 [Up to Day 85]
Dose normalized AUC of ABBV-141 will be assessed.
- Number of Adverse Events (AEs) [Baseline to Day 85]
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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).
-
Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal.
For Part 2 only:
-Han Chinese ethnicity or Japanese ethnicity based on the following criteria:
-
Han Chinese: First-generation Han Chinese with both parents of Han Chinese descent.
-
Japanese: First- or second-generation Japanese with both parents and all four grandparents born in Japan and of Japanese descent.
Exclusion Criteria:
Additionally for Part 1, only:
-
Presence of foreign bodies, local irritation or infections, active skin diseases, tattoos, and/or scars on the thighs which may preclude the skin biopsy collection site planned as per schedule of activities.
-
History of bruising easily, bleeding disorders, thrombocytopenia, or hypo-coagulation disorder.
-
History of sensitivity to or allergies to adhesives or evidence of fragile or easily damaged skin.
-
Evidence of hypertrophic scarring.
-
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, topical creams, or food.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- M24-693