Clinical trial NCT06895343: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Subcutaneous Doses of ABBV-701 in Healthy Adult Western and Asian Participants
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Subcutaneous Doses of ABBV-701 in Healthy Adult Western and Asian Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
ABBV-701
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-03-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous (SC) ABBV-701 in healthy adult western and Asian participants.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG
* Part 2 only:

For 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 consuming a typical Japanese diet.

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.

Exclusion Criteria:

* History of any clinically significant cardiovascular, respiratory (except mild asthma as a child), renal, endocrine, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of any clinically significant sensitivity or allergy to any medication or food.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to approximately 47 weeks
measure: Maximum Plasma Concentration (Cmax) of ABBV-701
timeFrame: Up to approximately 47 weeks
measure: Time to Cmax (Tmax) of ABBV-701
timeFrame: Up to approximately 47 weeks
measure: Apparent terminal phase elimination rate constant (β) of ABBV-701
timeFrame: Up to approximately 47 weeks
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-701
timeFrame: Up to approximately 47 weeks
measure: Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-701
timeFrame: Up to approximately 47 weeks
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-701
timeFrame: Up to approximately 47 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 273354
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: