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.
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
- Are there results?
- Not yet: the study is under way
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.
United States1 site, 1 recruiting
- Recruiting
Acpru /Id# 279789
Grayslake, Illinois, 60030
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
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
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07306754
- Acronym / sponsor ID
- M25-776
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1: ABBV-243 or Placebo | Experimental | Drug: ABBV-243, Drug: PlaceboParticipants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1 |
| Group 2: ABBV-243 or Placebo | Experimental | Drug: ABBV-243, Drug: PlaceboParticipants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1 |
| Group 3: ABBV-243 or Placebo | Experimental | Drug: ABBV-243, Drug: PlaceboParticipants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1 |
| Group 4: ABBV-243 or Placebo | Experimental | Drug: ABBV-243, Drug: PlaceboParticipants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1 |
| Group 5: ABBV-243 or Placebo | Experimental | Drug: ABBV-243, Drug: PlaceboParticipants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1 |
| Group 6: ABBV-243 or Placebo | Experimental | Drug: ABBV-243, Drug: PlaceboParticipants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1 |
| Group 7: ABBV-243 or Placebo | Experimental | Drug: ABBV-243, Drug: PlaceboHan Chinese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1 |
| Group 8: ABBV-243 or Placebo | Experimental | Drug: ABBV-243, Drug: PlaceboJapanese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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:
- Females, Childbearing Potential are defined as all other females who do not meet the above criteria and must adhere to the following:
- Part 2 only:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-243Intravenous (IV) Infusion | Drug | 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 |
| PlaceboIntravenous (IV) Infusion | Drug | 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-243Subcutaneous (SC) Injection | Drug | Group 5: ABBV-243 or Placebo, Group 6: ABBV-243 or Placebo |
| PlaceboSubcutaneous (SC) Injection | Drug | Group 5: ABBV-243 or Placebo, Group 6: ABBV-243 or Placebo |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 204
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.
Maximum Observed Serum Concentration (Cmax) of ABBV-243
Time frame: Up to Day 204
Maximum observed serum concentration (Cmax) of ABBV-243
Time to Cmax (Tmax) of ABBV-243
Time frame: Up to Day 204
Time to Cmax (Tmax) of ABBV-243
Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-243
Time frame: Up to Day 204
Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-243
Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-243
Time frame: Up to Day 204
AUC from time 0 to infinite time (AUCinf) of ABBV-243
Terminal Phase Elimination Rate Constant (β) of ABBV-243
Time frame: Up to Day 204
Terminal phase elimination rate constant of ABBV-243
Terminal Phase Elimination Half-Life (t1/2) of ABBV-243
Time frame: Up to Day 204
Terminal phase elimination half-life of ABBV-243
Anti-Drug Antibody (ADA) of ABBV-243
Time frame: Up to Day 204
Confirmed Positive ADA Results.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-243 in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Up to Day 204). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.