Healthy VolunteersPhase 1NCT07673120
A Study to Assess Safety, Tolerability, and How Single and Multiple Injections or Infusions of ABBV-313 Affects the Body of Adult Participants
A Phase 1 study testing ABBV-313 in people with Healthy Volunteers, run by AbbVie at 2 sites in United States.
Trial summary
The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ABBV-313
- Type of treatment
- 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
- 24 Jun 2026to Feb 2028
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI is >= 18.0 to <= 29.9 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 ECG.
Who cannot join
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.
- Participant has prior exposure to ABBV-313 within the past 300 days.
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# 285208
Anaheim, California, 92801
- Recruiting
Acpru /Id# 283495
Grayslake, Illinois, 60030
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses and Multiple Doses of ABBV-313
The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- ABBV-313, Placebo
- Keywords
- Healthy Volunteers, ABBV-313
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-313Drug
Injection
PlaceboDrug
Injection
ABBV-313Drug
Infusion
PlaceboDrug
Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Group 1: ABBV-313 or Placebo | Experimental | Participants will receive a single dose of ABBV-313 or Placebo Receives: Drug: ABBV-313; Drug: Placebo |
| Part 1, Group 2: ABBV-313 or Placebo | Experimental | Participants will receive a single dose of ABBV-313 or Placebo Receives: Drug: ABBV-313; Drug: Placebo |
| Part 1, Group 3: ABBV-313 or Placebo | Experimental | Participants will receive a single dose of ABBV-313 or Placebo Receives: Drug: ABBV-313; Drug: Placebo |
| Part 1, Group 4: ABBV-313 or Placebo | Experimental | Participants will receive a single dose of ABBV-313 or Placebo Receives: Drug: ABBV-313; Drug: Placebo |
| Part 1, Group 5: ABBV-313 or Placebo | Experimental | Participants will receive a single dose of ABBV-313 or Placebo Receives: Drug: ABBV-313; Drug: Placebo |
| Part 1, Group 6: ABBV-313 or Placebo | Experimental | Participants will receive a single dose of ABBV-313 or Placebo Receives: Drug: ABBV-313; Drug: Placebo |
| Part 2, Group 7: ABBV-313 or Placebo | Experimental | Participants will receive multiple doses of ABBV-313 or Placebo Receives: Drug: ABBV-313; Drug: Placebo |
| Part 2, Group 8: ABBV-313 or Placebo | Experimental | Participants will receive multiple doses of ABBV-313 or Placebo Receives: Drug: ABBV-313; 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 in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately Day 329
Maximum Observed Plasma Concentration (Cmax) of ABBV-313
Cmax of ABBV-313.
Measured: Up to Approximately Day 329
Time to Cmax (Tmax) of ABBV-313
Tmax of ABBV-313.
Measured: Up to Approximately Day 329
Terminal Phase Elimination Rate Constant (Beta) of ABBV-313
Beta of ABBV-313.
Measured: Up to Approximately Day 329
Terminal Phase Elimination Half-Life (t1/2) of ABBV-313
t1/2 of ABBV-313.
Measured: Up to Approximately Day 329
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-313
AUCt of ABBV-313.
Measured: Up to Approximately Day 329
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start24 Jun 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT07673120
- Sponsor's protocol ID
- M26-216
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2026
- Last updated
- 28 Sep 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses and Multiple Doses of ABBV-313
- ClinicalTrials.gov ID
- NCT07673120
- Acronym / sponsor ID
- M26-216
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, ABBV-313
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 29 Jun 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 safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1, Group 1: ABBV-313 or Placebo | Experimental | Drug: ABBV-313, Drug: PlaceboParticipants will receive a single dose of ABBV-313 or Placebo |
| Part 1, Group 2: ABBV-313 or Placebo | Experimental | Drug: ABBV-313, Drug: PlaceboParticipants will receive a single dose of ABBV-313 or Placebo |
| Part 1, Group 3: ABBV-313 or Placebo | Experimental | Drug: ABBV-313, Drug: PlaceboParticipants will receive a single dose of ABBV-313 or Placebo |
| Part 1, Group 4: ABBV-313 or Placebo | Experimental | Drug: ABBV-313, Drug: PlaceboParticipants will receive a single dose of ABBV-313 or Placebo |
| Part 1, Group 5: ABBV-313 or Placebo | Experimental | Drug: ABBV-313, Drug: PlaceboParticipants will receive a single dose of ABBV-313 or Placebo |
| Part 1, Group 6: ABBV-313 or Placebo | Experimental | Drug: ABBV-313, Drug: PlaceboParticipants will receive a single dose of ABBV-313 or Placebo |
| Part 2, Group 7: ABBV-313 or Placebo | Experimental | Drug: ABBV-313, Drug: PlaceboParticipants will receive multiple doses of ABBV-313 or Placebo |
| Part 2, Group 8: ABBV-313 or Placebo | Experimental | Drug: ABBV-313, Drug: PlaceboParticipants will receive multiple doses of ABBV-313 or Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI is >= 18.0 to <= 29.9 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 ECG.
Key exclusion criteria (3 listed)
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.
- Participant has prior exposure to ABBV-313 within the past 300 days.
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-313Injection | Drug | Part 1, Group 1: ABBV-313 or Placebo, Part 1, Group 2: ABBV-313 or Placebo, Part 1, Group 5: ABBV-313 or Placebo, Part 2, Group 7: ABBV-313 or Placebo, Part 2, Group 8: ABBV-313 or Placebo |
| PlaceboInjection | Drug | Part 1, Group 1: ABBV-313 or Placebo, Part 1, Group 2: ABBV-313 or Placebo, Part 1, Group 5: ABBV-313 or Placebo, Part 2, Group 7: ABBV-313 or Placebo, Part 2, Group 8: ABBV-313 or Placebo |
| ABBV-313Infusion | Drug | Part 1, Group 3: ABBV-313 or Placebo, Part 1, Group 4: ABBV-313 or Placebo, Part 1, Group 6: ABBV-313 or Placebo |
| PlaceboInfusion | Drug | Part 1, Group 3: ABBV-313 or Placebo, Part 1, Group 4: ABBV-313 or Placebo, Part 1, Group 6: ABBV-313 or Placebo |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to Approximately Day 329
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Maximum Observed Plasma Concentration (Cmax) of ABBV-313
Time frame: Up to Approximately Day 329
Cmax of ABBV-313.
Time to Cmax (Tmax) of ABBV-313
Time frame: Up to Approximately Day 329
Tmax of ABBV-313.
Terminal Phase Elimination Rate Constant (Beta) of ABBV-313
Time frame: Up to Approximately Day 329
Beta of ABBV-313.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-313
Time frame: Up to Approximately Day 329
t1/2 of ABBV-313.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-313
Time frame: Up to Approximately Day 329
AUCt of ABBV-313.
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 28 Sep 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-313 in people with Healthy Volunteers, 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 2 inclusion and 3 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 28 Sep 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 Approximately Day 329). The study lists 6 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 28 Sep 2026.