A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections
- Conditions
- Healthy Volunteer
- Interventions
- Drug: ABBV-547Drug: ABBV-547 Placebo
- Registration Number
- NCT07232004
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 87
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 1: ABBV-547 & Placebo ABBV-547 Participants will receive either ABBV-547 or placebo. Group 1: ABBV-547 & Placebo ABBV-547 Placebo Participants will receive either ABBV-547 or placebo. Group 3: ABBV-547 & Placebo ABBV-547 Participants will receive either ABBV-547 or placebo. Group 4: ABBV-547 & Placebo ABBV-547 Participants will receive either ABBV-547 or placebo. Group 2: ABBV-547 & Placebo ABBV-547 Participants will receive either ABBV-547 or placebo. Group 3: ABBV-547 & Placebo ABBV-547 Placebo Participants will receive either ABBV-547 or placebo. Group 2: ABBV-547 & Placebo ABBV-547 Placebo Participants will receive either ABBV-547 or placebo. Group 4: ABBV-547 & Placebo ABBV-547 Placebo Participants will receive either ABBV-547 or placebo. Group 5: ABBV-547 & Placebo ABBV-547 Participants will receive either ABBV-547 or placebo. Group 5: ABBV-547 & Placebo ABBV-547 Placebo Participants will receive either ABBV-547 or placebo. Group 6: ABBV-547 & Placebo ABBV-547 Participants will receive either ABBV-547 or placebo. Group 6: ABBV-547 & Placebo ABBV-547 Placebo Participants will receive either ABBV-547 or placebo.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) Up to Approximately Day 365 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.
- Secondary Outcome Measures
Name Time Method