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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: Placebo; Drug: ABBV-243; Drug: ABBV-243

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Recruiting
      • Acpru /Id# 279789

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Placebo; Intravenous (IV) Infusion; Drug: Placebo; Subcutaneous (SC) Injection; Drug: ABBV-243; Intravenous (IV) Infusion; Drug: ABBV-243; Subcutaneous (SC) Injection
Experimental: 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	Drug: Placebo; Intravenous (IV) Infusion; Drug: Placebo; Subcutaneous (SC) Injection; Drug: ABBV-243; Intravenous (IV) Infusion; Drug: ABBV-243; Subcutaneous (SC) Injection
Experimental: 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	Drug: Placebo; Intravenous (IV) Infusion; Drug: Placebo; Subcutaneous (SC) Injection; Drug: ABBV-243; Intravenous (IV) Infusion; Drug: ABBV-243; Subcutaneous (SC) Injection
Experimental: 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	Drug: Placebo; Intravenous (IV) Infusion; Drug: Placebo; Subcutaneous (SC) Injection; Drug: ABBV-243; Intravenous (IV) Infusion; Drug: ABBV-243; Subcutaneous (SC) Injection
Experimental: 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	Drug: Placebo; Intravenous (IV) Infusion; Drug: Placebo; Subcutaneous (SC) Injection; Drug: ABBV-243; Intravenous (IV) Infusion; Drug: ABBV-243; Subcutaneous (SC) Injection
Experimental: 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	Drug: Placebo; Intravenous (IV) Infusion; Drug: Placebo; Subcutaneous (SC) Injection; Drug: ABBV-243; Intravenous (IV) Infusion; Drug: ABBV-243; Subcutaneous (SC) Injection
Experimental: 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	Drug: Placebo; Intravenous (IV) Infusion; Drug: Placebo; Subcutaneous (SC) Injection; Drug: ABBV-243; Intravenous (IV) Infusion; Drug: ABBV-243; Subcutaneous (SC) Injection
Experimental: 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	Drug: Placebo; Intravenous (IV) Infusion; Drug: Placebo; Subcutaneous (SC) Injection; Drug: ABBV-243; Intravenous (IV) Infusion; Drug: ABBV-243; Subcutaneous (SC) Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs)	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.	Up to Day 204
Maximum Observed Serum Concentration (Cmax) of ABBV-243	Maximum observed serum concentration (Cmax) of ABBV-243	Up to Day 204
Time to Cmax (Tmax) of ABBV-243	Time to Cmax (Tmax) of ABBV-243	Up to Day 204
Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-243	Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-243	Up to Day 204
Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-243	AUC from time 0 to infinite time (AUCinf) of ABBV-243	Up to Day 204
Terminal Phase Elimination Rate Constant (β) of ABBV-243	Terminal phase elimination rate constant of ABBV-243	Up to Day 204
Terminal Phase Elimination Half-Life (t1/2) of ABBV-243	Terminal phase elimination half-life of ABBV-243	Up to Day 204
Anti-Drug Antibody (ADA) of ABBV-243	Confirmed Positive ADA Results.	Up to Day 204

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Estimated): December 29, 2025

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: M25-776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No