How ABBV-547 injections travel through the body and are tolerated by healthy adults
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
This trial will test a single injection of ABBV-547 versus placebo in healthy adult volunteers to see how the drug moves through the body and whether it is safe and tolerated.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 87 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 2 sites (Anaheim, California and 1 other locations) |
| Trial ID | NCT07232004 on ClinicalTrials.gov |
What this trial studies
This Phase 1, single-dose study enrolls about 87 healthy adults across roughly 21 sites in the United States and Japan to measure pharmacokinetics and tolerability of ABBV-547. The study has two parts with participants randomized into three active-dose groups or placebo (about a 1-in-4 chance of placebo in Part 1 and 1-in-7 in Part 2). Participants receive one dose of ABBV-547 or placebo and return for regular clinic visits for blood tests, ECGs, medical assessments, and safety monitoring. The main objectives are to characterize how the drug moves through the body and to record any adverse events or tolerability issues.
Who should consider this trial
Good fit: Healthy adult volunteers who pass screening exams, meet Part 1 BMI limits (18.0–29.9 kg/m2) or Part 2 washout requirements (e.g., discontinued phototherapy or certain agents), and can attend clinic visits are the intended participants.
Not a fit: People with significant allergies or underlying health issues, or those who recently used biologic agents or herbal supplements (per Part 2 exclusions), are unlikely to receive direct medical benefit from participation.
Why it matters
Potential benefit: If ABBV-547 is shown to be safe and tolerated, the results could guide dosing and safety monitoring in future patient-focused studies.
How similar studies have performed: Single-dose pharmacokinetic and tolerability studies of other investigational injections have commonly provided useful safety and dosing information, but ABBV-547 itself is a novel agent without established clinical efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Where this trial is running
Anaheim, California and 1 other locations
- CenExel ACT- Anaheim Clinical Trials /ID# 279612 — Anaheim, California, United States (Recruiting)
- Acpru /Id# 278638 — Grayslake, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.