Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGABBV-243
Intravenous (IV) Infusion
DRUGPlacebo
Intravenous (IV) Infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-243 | Up to Day 204 | AUC from time 0 to infinite time (AUCinf) of ABBV-243 |
| Terminal Phase Elimination Rate Constant (β) of ABBV-243 | Up to Day 204 | Terminal phase elimination rate constant of ABBV-243 |
| Number of Participants with Adverse Events (AEs) | Up to Day 204 | An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Maximum Observed Serum Concentration (Cmax) of ABBV-243 | Up to Day 204 | Maximum observed serum concentration (Cmax) of ABBV-243 |
| Time to Cmax (Tmax) of ABBV-243 | Up to Day 204 | Time to Cmax (Tmax) of ABBV-243 |
| Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-243 | Up to Day 204 | Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-243 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-243 | Up to Day 204 | Terminal phase elimination half-life of ABBV-243 |
| Anti-Drug Antibody (ADA) of ABBV-243 | Up to Day 204 | Confirmed Positive ADA Results. |
Countries
United States
Contacts
Primary ContactABBVIE CALL CENTER
Outcome results
None listed