A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections
A First-in-Human, Phase 1a/b, Single-Dose Study of ABBV-547 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Adult Participants and Efficacy in Adult Participants
1 other identifier
interventional
87
1 country
2
Brief Summary
The purpose of this study is to assess how safe, effective, and tolerable ABBV-547 is in adult participants in the United States and Japan. There will be 2 parts to this study. In Part 1, participants are placed in one of 3 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 4 chance participants will receive placebo. In Part 2, participants are placed in one of 3 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 7 chance participants will receive placebo. Approximately 87 adult participants will be enrolled at approximately 21 sites in the United States and Japan. Participants will be administered one dose of ABBV-547 or placebo. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 17, 2025
CompletedStudy Start
First participant enrolled
November 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
March 5, 2026
March 1, 2026
1.8 years
November 14, 2025
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to Approximately Day 365
Study Arms (6)
Group 1: ABBV-547 & Placebo
EXPERIMENTALParticipants will receive either ABBV-547 or placebo.
Group 2: ABBV-547 & Placebo
EXPERIMENTALParticipants will receive either ABBV-547 or placebo.
Group 3: ABBV-547 & Placebo
EXPERIMENTALParticipants will receive either ABBV-547 or placebo.
Group 4: ABBV-547 & Placebo
EXPERIMENTALParticipants will receive either ABBV-547 or placebo.
Group 5: ABBV-547 & Placebo
EXPERIMENTALParticipants will receive either ABBV-547 or placebo.
Group 6: ABBV-547 & Placebo
EXPERIMENTALParticipants will receive either ABBV-547 or placebo.
Interventions
Injection
Injection
Eligibility Criteria
You may qualify if:
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
- Part 1: BMI is \>= 18.0 to \<= 29.9 kg/m\^2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Part 2: must have discontinued use of phototherapy (e.g., UVA or UVB) at least 2 weeks prior to the baseline visit (Day 1) and PUVA phototherapy at least 4 weeks prior to the baseline visit (Day 1).
You may not qualify if:
- History of any clinically significant sensitivity or allergy to any medication or food.
- Part 2: uses any herbal supplements within the 2-week period prior to study treatment administration.
- Part 2: received any biologics including investigational agents within 2.5 half-lives prior to Baseline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (2)
CenExel ACT- Anaheim Clinical Trials /ID# 279612
Anaheim, California, 92801, United States
Acpru /Id# 278638
Grayslake, Illinois, 60030, United States
Related Links
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 17, 2025
Study Start
November 24, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share