Healthy VolunteerPhase 1NCT07736638
A Study to Assess the Safety, Tolerability and How Single Ascending Doses of ABBV-859 Moves Through the Body of Healthy Adult Participants
A Phase 1 study testing ABBV-859 in people with Healthy Volunteer, run by AbbVie at 2 sites in United States.
Trial summary
The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-859 after single ascending doses in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-859
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jul 2026to Feb 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- Body Mass Index (BMI) is >= 18.0 to <= 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).
Who cannot join
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, endocrine, immunological, pulmonary, metabolic, neurological or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
- 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 disease or latent Tuberculosis infection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
CenExel ACT- Anaheim Clinical Trials /ID# 284382
Anaheim, California, 92801
- Recruiting
Acpru /Id# 284029
Grayslake, Illinois, 60030
About this study
Official title: A First-in-Human, Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-859 After Single Ascending Doses in Healthy Adult Subjects
The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-859 after single ascending doses in healthy adult volunteers.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-859, Placebo for ABBV-859
- Keywords
- Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-859Drug
Oral Tablet
Placebo for ABBV-859Drug
Oral Tablet
ABBV-859Drug
Intravenous (IV) Infusion
Placebo for ABBV-859Drug
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive either ABBV-859 single Dose A, or the Placebo equivalent, on Study Day 1 Receives: Drug: ABBV-859; Drug: Placebo for ABBV-859 |
| Group 2 | Experimental | Participants will receive either ABBV-859 single Dose B, or the Placebo equivalent, on Study Day 1 Receives: Drug: ABBV-859; Drug: Placebo for ABBV-859 |
| Group 3 | Experimental | Participants will receive either ABBV-859 single Dose C, or the Placebo equivalent, on Study Day 1 Receives: Drug: ABBV-859; Drug: Placebo for ABBV-859 |
| Group 4 | Experimental | Participants will receive either ABBV-859 single Dose D, or the Placebo equivalent, on Study Day 1 Receives: Drug: ABBV-859; Drug: Placebo for ABBV-859 |
| Group 5 | Experimental | Participants will receive either ABBV-859 single Dose E, or the Placebo equivalent, on Study Day 1 Receives: Drug: ABBV-859; Drug: Placebo for ABBV-859 |
| Group 6 | Experimental | Participants will receive either ABBV-859 single Dose F, or the Placebo equivalent, on Study Day 1 Receives: Drug: ABBV-859; Drug: Placebo for ABBV-859 |
| Group 7 | Experimental | Participants will receive either ABBV-859 single Dose G, or the Placebo equivalent, on Study Day 1 Receives: Drug: ABBV-859; Drug: Placebo for ABBV-859 |
| Group 8 | Experimental | Participants will receive either ABBV-859 single Dose H, or the Placebo equivalent, on Study Day 1 Receives: Drug: ABBV-859; Drug: Placebo for ABBV-859 |
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 adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
Measured: Up to 99 Days
Maximum Observed Serum Concentration (Cmax) of ABBV-859
Cmax of ABBV-859
Measured: Up to 99 Days
Time to Cmax (Tmax) of ABBV-859
Time to Cmax (Tmax) of ABBV-859
Measured: Up to 99 Days
Terminal Phase Elimination Rate Constant (Beta) of ABBV-859
Beta of ABBV-859
Measured: Up to 99 Days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-859
t1/2 of ABBV-859
Measured: Up to 99 Days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-859
AUCt of ABBV-859
Measured: Up to 99 Days
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-859
AUCinf of ABBV-859
Measured: Up to 99 Days
Apparent Clearance (CL/F) ABBV-859
CL/F of ABBV-859
Measured: Up to 99 Days
Antidrug Antibody (ADA)
Incidence and concentration of anti-drug antibodies.
Measured: Up to 99 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start28 Jul 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 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
- NCT07736638
- Sponsor's protocol ID
- M25-924
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-859 After Single Ascending Doses in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07736638
- Acronym / sponsor ID
- M25-924
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 30 Jul 2026 (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 pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-859 after single ascending doses in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: ABBV-859, Drug: Placebo for ABBV-859Participants will receive either ABBV-859 single Dose A, or the Placebo equivalent, on Study Day 1 |
| Group 2 | Experimental | Drug: ABBV-859, Drug: Placebo for ABBV-859Participants will receive either ABBV-859 single Dose B, or the Placebo equivalent, on Study Day 1 |
| Group 3 | Experimental | Drug: ABBV-859, Drug: Placebo for ABBV-859Participants will receive either ABBV-859 single Dose C, or the Placebo equivalent, on Study Day 1 |
| Group 4 | Experimental | Drug: ABBV-859, Drug: Placebo for ABBV-859Participants will receive either ABBV-859 single Dose D, or the Placebo equivalent, on Study Day 1 |
| Group 5 | Experimental | Drug: ABBV-859, Drug: Placebo for ABBV-859Participants will receive either ABBV-859 single Dose E, or the Placebo equivalent, on Study Day 1 |
| Group 6 | Experimental | Drug: ABBV-859, Drug: Placebo for ABBV-859Participants will receive either ABBV-859 single Dose F, or the Placebo equivalent, on Study Day 1 |
| Group 7 | Experimental | Drug: ABBV-859, Drug: Placebo for ABBV-859Participants will receive either ABBV-859 single Dose G, or the Placebo equivalent, on Study Day 1 |
| Group 8 | Experimental | Drug: ABBV-859, Drug: Placebo for ABBV-859Participants will receive either ABBV-859 single Dose H, or the Placebo equivalent, on Study Day 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- Body Mass Index (BMI) is >= 18.0 to <= 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).
Key exclusion criteria (5 listed)
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, endocrine, immunological, pulmonary, metabolic, neurological or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
- 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 disease or latent Tuberculosis 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-859Oral Tablet | Drug | Group 5, Group 6, Group 7, Group 8 |
| Placebo for ABBV-859Oral Tablet | Drug | Group 5, Group 6, Group 7, Group 8 |
| ABBV-859Intravenous (IV) Infusion | Drug | Group 1, Group 2, Group 3, Group 4 |
| Placebo for ABBV-859Intravenous (IV) Infusion | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to 99 Days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
Maximum Observed Serum Concentration (Cmax) of ABBV-859
Time frame: Up to 99 Days
Cmax of ABBV-859
Time to Cmax (Tmax) of ABBV-859
Time frame: Up to 99 Days
Time to Cmax (Tmax) of ABBV-859
Terminal Phase Elimination Rate Constant (Beta) of ABBV-859
Time frame: Up to 99 Days
Beta of ABBV-859
Terminal Phase Elimination Half-Life (t1/2) of ABBV-859
Time frame: Up to 99 Days
t1/2 of ABBV-859
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-859
Time frame: Up to 99 Days
AUCt of ABBV-859
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-859
Time frame: Up to 99 Days
AUCinf of ABBV-859
Apparent Clearance (CL/F) ABBV-859
Time frame: Up to 99 Days
CL/F of ABBV-859
Antidrug Antibody (ADA)
Time frame: Up to 99 Days
Incidence and concentration of anti-drug antibodies.
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 3 Aug 2026.
- Individual participant dataSharing planned: No
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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
2 sites 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-859 in people with Healthy Volunteer, run by AbbVie at 2 sites 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 3 inclusion and 5 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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 99 Days). The study lists 9 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 3 Aug 2026.