BridgeMD
Tests treatment safety and results for Healthy Volunteers
Official title A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.
ClinicalTrials.gov ID: NCT07306754
What this study is testing
What is ABBV-243?
ABBV-243 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join 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...
- 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...
You likely can't join if
- History: of epilepsy, any clinically significant cardiovascular, respiratory (except mild asthma as a child), renal, endocrine, hepatic...
- 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...
- History or evidence of active Tuberculosis (TB) disease or latent TB infection.
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Grayslake, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grayslake, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.