Status:
RECRUITING
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The objective of this study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK ) properties following a single dose of ABBV-277 in healthy adult participants.
Eligibility Criteria
Inclusion
- Body weight ≥ 35 kg
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile neurological examination, and a 12-lead ECG
Exclusion
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- Participant must meet pregnancy/conception/partner considerations criteria as detailed in the eligibility section.
- Participants using any medications, vitamins and/or herbal supplements within the 14-day period prior to study drug administration or within 5 half-lives of the respective medication, whichever is longer.
- 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.
- History of suicidal ideation currently or within one year prior to study drug administration as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the C - SSRS completed at screening, or any history of suicide attempts within the last two years.
Key Trial Info
Start Date :
August 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07136103
Start Date
August 19 2025
End Date
May 1 2026
Last Update
September 2 2025
Active Locations (1)
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1
Acpru /Id# 265681
Grayslake, Illinois, United States, 60030