A Study to Assess Safety, Tolerability, and How Single and Multiple Injections or Infusions of ABBV-313 Affects the Body of Adult Participants
Purpose
The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult participants.
Condition
- Healthy Volunteers
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- BMI is >= 18.0 to <= 29.9 kg/m2 after rounding to the tenths decimal at Screening. 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.
Exclusion Criteria
- History of any clinically significant sensitivity or allergy to any medication or food. - 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 treatment. - Participant has prior exposure to ABBV-313 within the past 300 days.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1, Group 1: ABBV-313 or Placebo |
Participants will receive a single dose of ABBV-313 or Placebo |
|
|
Experimental Part 1, Group 2: ABBV-313 or Placebo |
Participants will receive a single dose of ABBV-313 or Placebo |
|
|
Experimental Part 1, Group 3: ABBV-313 or Placebo |
Participants will receive a single dose of ABBV-313 or Placebo |
|
|
Experimental Part 1, Group 4: ABBV-313 or Placebo |
Participants will receive a single dose of ABBV-313 or Placebo |
|
|
Experimental Part 1, Group 5: ABBV-313 or Placebo |
Participants will receive a single dose of ABBV-313 or Placebo |
|
|
Experimental Part 1, Group 6: ABBV-313 or Placebo |
Participants will receive a single dose of ABBV-313 or Placebo |
|
|
Experimental Part 2, Group 7: ABBV-313 or Placebo |
Participants will receive multiple doses of ABBV-313 or Placebo |
|
|
Experimental Part 2, Group 8: ABBV-313 or Placebo |
Participants will receive multiple doses of ABBV-313 or Placebo |
|
Recruiting Locations
Acpru /Id# 283495
Grayslake, Illinois 60030
Grayslake, Illinois 60030
More Details
- Status
- Recruiting
- Sponsor
- AbbVie