What this study is
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.
What's being tested
- ABBV-243
Intervention · DRUG
- Placebo
Intervention · DRUG
- ABBV-243
Intervention · DRUG
- Placebo
Intervention · DRUG
Both ABBV-243 and Placebo
Intravenous (IV) Infusion
Both ABBV-243 and Placebo
Subcutaneous (SC) Injection
Study details
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses (SAD) of ABBV-243 in Healthy Adult Subjects and a Single Dose in Healthy Asian Adult Subjects
- Sponsor
- AbbVie
- Conditions
- Healthy Volunteers
- Enrolling
- 66 people
- Starts
- 2025-12-17
- Est. completion
- 2027-05
- Design
- Double-blind, randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 60 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Individuals between 18 and 60 years of age inclusive at the time of Screening.
- BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth's decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Females, Non-Childbearing Potential are eligible as defined by meeting the following criteria:; Permanent sterility due to a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.; Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry.; Postmenopausal female who is age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level ≥ 30 IU/L.; Postmenopausal female who is age > 55 years with no menses for 12 or more months without an alternative medical cause.
- Females, Childbearing Potential are defined as all other females who do not meet the above criteria and must adhere to the following:; Must not be pregnant or breastfeeding.; Must agree to avoid pregnancy while taking study treatment(s) and for at least 200 days after the last dose of study treatment.; Must agree to use a contraceptive method listed below (as per local regulations) that is highly effective (with a failure rate of < 1% per year, when used consistently and correctly). Participants must provide documentation to the site.; Bilateral tubal occlusion/ligation.; Intrauterine device (IUD) to be inserted at least 30 days prior to Screening.; Intrauterine hormone-releasing system (IUS) to be inserted at least 30 days prior to Screening.
- Part 2 only: Healthy Japanese and Han Chinese male or female; between 18 and 60 years of age, inclusive at the time of Screening.
- Han Chinese participants must be first- or second-generation Han Chinese of full Chinese parentage. First-generation participants are defined as those born in China to two parents and four grandparents also born in China of full Chinese descent. Second-generation participants are defined as those born outside of China to two parents and four grandparents born in China of full Chinese descent. OR
- Japanese participants must be first- or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation subjects born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent.
You can't join if
- History: of epilepsy, any clinically significant cardiovascular, respiratory (except mild asthma as a child), renal, endocrine, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma, or localized carcinoma in situ of the cervix.
- History or evidence of active Tuberculosis (TB) disease or latent TB infection.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openAcpru /Id# 279789
Grayslake, Illinois, United States
Recruiting
Study team
Sponsor
AbbVie
Study ID M25-776
Study director
ABBVIE INC.
AbbVie
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.