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A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults. | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.

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

NCT07306754•AbbVie

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

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.
+9 more criteria

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.

Locations (1)

Acpru /Id# 279789

Grayslake, Illinois, United States

Key Dates

Start Date

December 17, 2025

Primary Completion Date

May 1, 2027

Completion Date

May 1, 2027

Last Updated

January 12, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy Volunteers

Interventions

ABBV-243

DRUG

Placebo

DRUG

ABBV-243

DRUG

Placebo

DRUG

Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.

Inclusion Criteria

Exclusion Criteria

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