A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.
NCT ID: NCT07306754
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
66 participants
INTERVENTIONAL
2025-12-15
2027-05-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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Group 2: ABBV-243 or Placebo
Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1
ABBV-243
Intravenous (IV) Infusion
Placebo
Intravenous (IV) Infusion
Group 3: ABBV-243 or Placebo
Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1
ABBV-243
Intravenous (IV) Infusion
Placebo
Intravenous (IV) Infusion
Group 4: ABBV-243 or Placebo
Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1
ABBV-243
Intravenous (IV) Infusion
Placebo
Intravenous (IV) Infusion
Group 5: ABBV-243 or Placebo
Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1
ABBV-243
Subcutaneous (SC) Injection
Placebo
Subcutaneous (SC) Injection
Group 6: ABBV-243 or Placebo
Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1
ABBV-243
Subcutaneous (SC) Injection
Placebo
Subcutaneous (SC) Injection
Group 7: ABBV-243 or Placebo
Han Chinese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1
ABBV-243
Intravenous (IV) Infusion
Placebo
Intravenous (IV) Infusion
Group 8: ABBV-243 or Placebo
Japanese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1
ABBV-243
Intravenous (IV) Infusion
Placebo
Intravenous (IV) Infusion
Group 1: ABBV-243 or Placebo
Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1
ABBV-243
Intravenous (IV) Infusion
Placebo
Intravenous (IV) Infusion
Interventions
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ABBV-243
Intravenous (IV) Infusion
Placebo
Intravenous (IV) Infusion
ABBV-243
Subcutaneous (SC) Injection
Placebo
Subcutaneous (SC) Injection
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
60 Years
ALL
Yes
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Acpru /Id# 279789
Grayslake, Illinois, United States
Countries
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Central Contacts
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Related Links
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Other Identifiers
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M25-776
Identifier Type: -
Identifier Source: org_study_id