ABBV-154Phase 1NCT05556226
Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy Participants
A Phase 1 study testing ABBV-154 Dose Formulation A and ABBV-154 Dose Formulation B in people with ABBV-154, run by AbbVie at 2 sites in United States.
Trial summary
This study will assess how safe ABBV-154 is and how ABBV-154 moves through the body of adult healthy participants. Adverse Events will be assessed. ABBV-154 is an investigational drug being developed for potential treatment of immune-mediated inflammatory diseases. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- ABBV-154
- What is being tested?
- ABBV-154 Dose Formulation A and ABBV-154 Dose Formulation B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Oct 2022to 17 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the nearest tenth at screening and upon initial confinement.
Who cannot join
- Participant using any medications, vitamins and/or herbal supplements, within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
- Prior exposure to similar biologic therapies.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Acpru /Id# 250429
Grayslake, Illinois, 60030
PPD Clinical Research Unit -Las Vegas /ID# 250650
Las Vegas, Nevada, 89113-2235
About this study
Official title: A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of ABBV-154
This study will assess how safe ABBV-154 is and how ABBV-154 moves through the body of adult healthy participants. Adverse Events will be assessed.
ABBV-154 is an investigational drug being developed for potential treatment of immune-mediated inflammatory diseases. Participants are randomly assigned to one of the 2 treatment groups. Approximately 40 adult healthy volunteers will be enrolled in 2 sites in the United States.
All participants will receive ABBV-154 as subcutaneous injections with one of the 2 different formulations.
There may be higher burden for participants in this trial. Participants will be confined for 9 days. Adverse Events and blood tests will be performed.
- Conditions
- ABBV-154
- Being tested
- ABBV-154 Dose Formulation A, ABBV-154 Dose Formulation B
- Keywords
- ABBV-154
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-154 Dose Formulation ADrug
Subcutaneous Injection
ABBV-154 Dose Formulation BDrug
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| ABBV-154 Dose A | Experimental | Participants will receive subcutaneous dose of ABBV-154 Dose Formulation A. Receives: Drug: ABBV-154 Dose Formulation A |
| ABBV-154 Dose B | Experimental | Participants will receive subcutaneous dose of ABBV-154 Dose Formulation B. Receives: Drug: ABBV-154 Dose Formulation B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration (Cmax)
Measured: Approximately up to 58 days
Time to Maximum Observed Plasma Concentration (Tmax)
Time to Maximum Observed Plasma Concentration (Tmax)
Measured: Approximately up to 58 days
Apparent Terminal Phase Elimination Rate Constant (β)
Apparent Terminal Phase Elimination Rate Constant (β)
Measured: Approximately up to 58 days
The Terminal Phase Elimination Half-Life (t1/2)
The Terminal Phase Elimination Half-Life (t1/2)
Measured: Approximately up to 58 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Measured: Approximately up to 58 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Measured: Approximately up to 58 days
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Measured: Approximately up to 72 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start18 Oct 2022
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ABBV-154Studies 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
- None (open label)
- Enrolment
- 40 participants (actual)
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
- NCT05556226
- Sponsor's protocol ID
- M23-506
- Status last verified
- Mar 2023
- First submitted
- 23 Sep 2022
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of ABBV-154
- ClinicalTrials.gov ID
- NCT05556226
- Acronym / sponsor ID
- M23-506
- Conditions
- ABBV-154
- Keywords
- ABBV-154
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 27 Sep 2022 (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.
This study will assess how safe ABBV-154 is and how ABBV-154 moves through the body of adult healthy participants. Adverse Events will be assessed.
ABBV-154 is an investigational drug being developed for potential treatment of immune-mediated inflammatory diseases. Participants are randomly assigned to one of the 2 treatment groups. Approximately 40 adult healthy volunteers will be enrolled in 2 sites in the United States.
All participants will receive ABBV-154 as subcutaneous injections with one of the 2 different formulations.
There may be higher burden for participants in this trial. Participants will be confined for 9 days. Adverse Events and blood tests will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABBV-154 Dose A | Experimental | Drug: ABBV-154 Dose Formulation AParticipants will receive subcutaneous dose of ABBV-154 Dose Formulation A. |
| ABBV-154 Dose B | Experimental | Drug: ABBV-154 Dose Formulation BParticipants will receive subcutaneous dose of ABBV-154 Dose Formulation B. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the nearest tenth at screening and upon initial confinement.
Key exclusion criteria (3 listed)
- Participant using any medications, vitamins and/or herbal supplements, within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
- Prior exposure to similar biologic therapies.
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-154 Dose Formulation ASubcutaneous Injection | Drug | ABBV-154 Dose A |
| ABBV-154 Dose Formulation BSubcutaneous Injection | Drug | ABBV-154 Dose B |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Approximately up to 58 days
Maximum Observed Plasma Concentration (Cmax)
Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Approximately up to 58 days
Time to Maximum Observed Plasma Concentration (Tmax)
Apparent Terminal Phase Elimination Rate Constant (β)
Time frame: Approximately up to 58 days
Apparent Terminal Phase Elimination Rate Constant (β)
The Terminal Phase Elimination Half-Life (t1/2)
Time frame: Approximately up to 58 days
The Terminal Phase Elimination Half-Life (t1/2)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Time frame: Approximately up to 58 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Time frame: Approximately up to 58 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Number of Participants with Adverse Events
Time frame: Approximately up to 72 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
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-154 Dose Formulation A and ABBV-154 Dose Formulation B in people with ABBV-154, 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 1 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: finished, as of the sponsor's last update on 13 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: Approximately up to 58 days). The study lists 7 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 13 Mar 2023.