A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants
NCT ID: NCT07136103
Last Updated: 2025-09-02
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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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2025-08-19
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
TRIPLE
Study Groups
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Group 1: ABBV-277-Dose A
Participants will receive ABBV-277 Dose A on day 1 and followed for 196 days
ABBV-277
• Intravenous (IV) infusion
Group 1: Placebo
Participants will receive Placebo on day 1 and followed for 196 days
Placebo
• Intravenous (IV) infusion
Group 2: ABBV-277-Dose B
Participants will receive ABBV-277 Dose B on day 1 and followed for 196 days
ABBV-277
• Intravenous (IV) infusion
Group 2: Placebo
Participants will receive Placebo on day 1 and followed for 196 days
Placebo
• Intravenous (IV) infusion
Group 3: ABBV-277-Dose C
Participants will receive ABBV-277 Dose C on day 1 and followed for 196 days
ABBV-277
• Intravenous (IV) infusion
Group 3: Placebo
Participants will receive Placebo on day 1 and followed for 196 days
Placebo
• Intravenous (IV) infusion
Group 4: ABBV-277-Dose D
Participants will receive ABBV-277 Dose D on day 1 and followed for 196 days
ABBV-277
• Intravenous (IV) infusion
Group 4: Placebo
Participants will receive Placebo on day 1 and followed for 196 days
Placebo
• Intravenous (IV) infusion
Group 5: ABBV-277-Dose E
Participants will receive ABBV-277 Dose E on day 1 and day 2 and followed for 196 days
ABBV-277
• Intravenous (IV) infusion
Group 5: Placebo
Participants will receive Placebo on day 1 and day 2 and followed for 196 days
Placebo
• Intravenous (IV) infusion
Interventions
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ABBV-277
• Intravenous (IV) infusion
Placebo
• Intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile neurological examination, and a 12-lead ECG
Exclusion Criteria
* Participant must meet pregnancy/conception/partner considerations criteria as detailed in the eligibility section.
* Participants using any medications, vitamins and/or herbal supplements within the 14-day period prior to study drug administration or within 5 half-lives of the respective medication, whichever is longer.
* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* History of suicidal ideation currently or within one year prior to study drug administration as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the C - SSRS completed at screening, or any history of suicide attempts within the last two years.
18 Years
65 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# 265681
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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M24-934
Identifier Type: -
Identifier Source: org_study_id
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