Actively Recruiting
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.
Led by AbbVie · Updated on 2026-01-12
66
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to assess the safety, tolerability, pharmacokinetics and immunogenicity of either single ascending intravenous (IV) doses of ABBV-243 or single ascending subcutaneous (SC) doses of ABBV-243 in healthy adult participants (Part 1), and a single intravenous (IV) dose in healthy Asian adult volunteers (Part 2 There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
CONDITIONS
Official Title
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals between 18 and 60 years of age inclusive at the time of Screening.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 at Screening.
- Females not able to have children due to permanent sterilization or postmenopause.
- Females able to have children must not be pregnant or breastfeeding and must agree to use highly effective contraception during and for 200 days after treatment.
- Healthy Japanese and Han Chinese adults aged 18 to 60 years in Part 2, with specific ancestry requirements.
You will not qualify if you...
- History of epilepsy or any significant cardiovascular, respiratory (except mild childhood asthma), kidney, endocrine, liver, gastrointestinal, blood, or psychiatric disease or any uncontrolled illness.
- History of significant allergy or sensitivity to medications or food.
- Evidence or history of cancer except certain treated skin or cervical cancers.
- History or evidence of active or latent tuberculosis (TB).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Acpru /Id# 279789
Grayslake, Illinois, United States, 60030
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
8
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