Healthy VolunteersPhase 1NCT07306754

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

A Phase 1 study testing ABBV-243 in people with Healthy Volunteers, run by AbbVie at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: ABBV-243
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteUnited States
Study dates: 17 Dec 2025to May 2027
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

United States1 site, 1 recruiting

Acpru /Id# 279789
Grayslake, Illinois, 60030
Recruiting

Other trials in United States

About this study

Official title: 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

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
Being tested: ABBV-243, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABBV-243Drug
Intravenous (IV) Infusion
PlaceboDrug
Intravenous (IV) Infusion
ABBV-243Drug
Subcutaneous (SC) Injection
PlaceboDrug
Subcutaneous (SC) Injection

Study groups in NCT07306754
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: ABBV-243; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to Day 204
Maximum Observed Serum Concentration (Cmax) of ABBV-243
Maximum observed serum concentration (Cmax) of ABBV-243
Measured: Up to Day 204
Time to Cmax (Tmax) of ABBV-243
Time to Cmax (Tmax) of ABBV-243
Measured: 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
Measured: 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
Measured: Up to Day 204
Terminal Phase Elimination Rate Constant (β) of ABBV-243
Terminal phase elimination rate constant of ABBV-243
Measured: Up to Day 204
Terminal Phase Elimination Half-Life (t1/2) of ABBV-243
Terminal phase elimination half-life of ABBV-243
Measured: Up to Day 204
Anti-Drug Antibody (ADA) of ABBV-243
Confirmed Positive ADA Results.
Measured: Up to Day 204

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 2025May 2027

First posted29 Dec 2025
Study start17 Dec 2025
Primary completionMay 2027 (estimated)
Study completionMay 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07306754
Sponsor's protocol ID: M25-776
Status last verified: Jan 2026
First submitted: 15 Dec 2025
Last updated: 12 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

ABBVIE CALL CENTER

844-663-3742

abbvieclinicaltrials@abbvie.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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