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

NCT07306754 | Recruiting Phase 1 FDA Drug

• 1 other identifier: M25-776
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (8)

Group 1: ABBV-243 or Placebo

EXPERIMENTAL

Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1

Drug: ABBV-243; Drug: Placebo

Group 2: ABBV-243 or Placebo

EXPERIMENTAL

Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1

Drug: ABBV-243; Drug: Placebo

Group 3: ABBV-243 or Placebo

EXPERIMENTAL

Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1

Drug: ABBV-243; Drug: Placebo

Group 4: ABBV-243 or Placebo

EXPERIMENTAL

Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1

Drug: ABBV-243; Drug: Placebo

Group 5: ABBV-243 or Placebo

EXPERIMENTAL

Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1

Drug: ABBV-243; Drug: Placebo

Group 6: ABBV-243 or Placebo

EXPERIMENTAL

Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1

Drug: ABBV-243; Drug: Placebo

Group 7: ABBV-243 or Placebo

EXPERIMENTAL

Han Chinese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1

Drug: ABBV-243; Drug: Placebo

Group 8: ABBV-243 or Placebo

EXPERIMENTAL

Japanese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1

Drug: ABBV-243; Drug: Placebo

Interventions

Placebo DRUG

Intravenous (IV) Infusion

Group 1: ABBV-243 or Placebo; Group 2: ABBV-243 or Placebo; Group 3: ABBV-243 or Placebo; Group 4: ABBV-243 or Placebo; Group 7: ABBV-243 or Placebo; Group 8: ABBV-243 or Placebo

ABBV-243 DRUG

Intravenous (IV) Infusion

Group 1: ABBV-243 or Placebo; Group 2: ABBV-243 or Placebo; Group 3: ABBV-243 or Placebo; Group 4: ABBV-243 or Placebo; Group 7: ABBV-243 or Placebo; Group 8: ABBV-243 or Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 279789

Grayslake, Illinois, 60030, United States

RECRUITING

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)