Clinical trial NCT06774313: A Study to Assess the Adverse Events and How Subcutaneous (SC) Injections and Intravenous (IV) Infusions of ABBV-142 Move Through the Body of Healthy Adult Participants
Official title: A Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses of ABBV-142 in Healthy Adult Subjects and Single Doses of ABBV-142 in Healthy Adult Asian Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
ABBV-142
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-01-14
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to assess the pharmacokinetic properties, safety, tolerability, and immunogenicity of ABBV-142 and determine whether predicted efficacious exposures can be safely achieved in humans.


Eligibility criteria: Inclusion Criteria:

All Parts:

• Volunteers in general good health.

Part 3, ONLY:

HAN CHINESE Participants:

* Participant must be first- or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
* First-generation participants will have been born in China to two parents and four grandparents, who were also born in China, and are of full Chinese descent.
* Second-generation participants born outside of China must have two parents and four grandparents born in China and are of full Chinese descent.

OR

JAPANESE Participants:

* Participant must be first- or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including diet.
* First-generation participants will have been born in Japan to two parents and four grandparents born in Japan and are of full Japanese descent.
* Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan and are of full Japanese descent.

Exclusion Criteria:

* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 120
measure: Maximum Observed Serum Concentration (Cmax) of ABBV-142
timeFrame: Up to Day 120
measure: Time to Cmax (Tmax) of ABBV-142
timeFrame: Up to Day 120
measure: Area Under the Serum Concentration-time Curve (AUC) of ABBV-142 from Time 0 to the Time of Last Measurable Concentration (AUCt)
timeFrame: Up to Day 120
measure: AUC of ABBV-142 from Time 0 to Infinity (AUCinf)
timeFrame: Up to Day 120
measure: Terminal Phase Elimination Rate Constant (β) of ABBV-142
timeFrame: Up to Day 120
measure: Terminal Phase Elimination Half-life (t1/2) of ABBV-142
timeFrame: Up to Day 120
measure: Dose Normalized Cmax of ABBV-142
timeFrame: Up to Day 120
measure: Dose Normalized AUC of ABBV-142
timeFrame: Up to Day 120
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 271899
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: