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
- Conditions
- Healthy Volunteer
- Interventions
- Drug: ABBV-701Drug: Placebo
- Registration Number
- NCT06895343
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 58
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Group 1 ABBV-701 or Placebo ABBV-701 Participants will receive a single dose of either ABBV-701 Dose A or placebo. Part 1: Group 1 ABBV-701 or Placebo Placebo Participants will receive a single dose of either ABBV-701 Dose A or placebo. Part 1: Group 2 ABBV-701 or Placebo ABBV-701 Participants will receive a single dose of either ABBV-701 Dose B or placebo. Part 1: Group 2 ABBV-701 or Placebo Placebo Participants will receive a single dose of either ABBV-701 Dose B or placebo. Part 1: Group 3 ABBV-701 or Placebo ABBV-701 Participants will receive a single dose of either ABBV-701 Dose C or placebo. Part 1: Group 3 ABBV-701 or Placebo Placebo Participants will receive a single dose of either ABBV-701 Dose C or placebo. Part 1: Group 4 ABBV-701 or Placebo ABBV-701 Participants will receive a single dose of either ABBV-701 Dose D or placebo. Part 1: Group 4 ABBV-701 or Placebo Placebo Participants will receive a single dose of either ABBV-701 Dose D or placebo. Part 1: Group 5 ABBV-701 or Placebo ABBV-701 Participants will receive a single dose of either ABBV-701 Dose E or placebo. Part 1: Group 5 ABBV-701 or Placebo Placebo Participants will receive a single dose of either ABBV-701 Dose E or placebo. Part 2: Group 6 ABBV-701 or Placebo ABBV-701 Participants will receive a single dose of either ABBV-701 Dose E or placebo. Part 2: Group 6 ABBV-701 or Placebo Placebo Participants will receive a single dose of either ABBV-701 Dose E or placebo. Part 2: Group 7 ABBV-701 or Placebo ABBV-701 Participants will receive a single dose of either ABBV-701 Dose E or placebo. Part 2: Group 7 ABBV-701 or Placebo Placebo Participants will receive a single dose of either ABBV-701 Dose E or placebo.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Adverse Events Up to approximately 47 weeks An 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.
Maximum Plasma Concentration (Cmax) of ABBV-701 Up to approximately 47 weeks Cmax of ABBV-701
Time to Cmax (Tmax) of ABBV-701 Up to approximately 47 weeks Tmax of ABBV-701
Apparent terminal phase elimination rate constant (β) of ABBV-701 Up to approximately 47 weeks (β) of ABBV-701
Terminal Phase Elimination Half-Life (t1/2) of ABBV-701 Up to approximately 47 weeks (t1/2) of ABBV-701
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-701 Up to approximately 47 weeks AUCt of ABBV-701
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-701 Up to approximately 47 weeks AUCinf of ABBV-701
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Acpru /Id# 273354
🇺🇸Grayslake, Illinois, United States