Healthy VolunteersPhase 1NCT06067568
Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participants
A Phase 1 study testing Lutikizumab Dose A and Lutikizumab Dose B in people with Healthy Volunteers, run by AbbVie at 3 sites in United States.
Trial summary
The purpose of this study is to compare the bioavailability of two different formulations of lutikizumab, and to assess adverse events (AEs) and how lutikizumab moves through the body in healthy Chinese participants. 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?
- Lutikizumab Dose A and Lutikizumab Dose B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Sep 2023to 26 Feb 2024
- 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
- Male and female healthy volunteers aged between 18 and 60 years.
- -- Part 2 only: Participant must be first-generation Han Chinese of full Chinese parentage residing outside of China. Participant must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
- BMI <= 18.0 to <= 29.9 kg/m^2 after rounding to the tenths decimal, at screening and upon initial confinement.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG).
Who cannot join
- Use 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 lutikizumab.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
PPD Clinical Research Unit - Austin /ID# 260141
Austin, Texas, 78744
Altasciences Clinical Los Angeles, Inc /ID# 260986
Cypress, California, 90630
Acpru /Id# 259029
Grayslake, Illinois, 60030
About this study
Official title: A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Lutikizumab Formulations and to Evaluate Lutikizumab Pharmacokinetics, Safety, and Tolerability in Healthy Chinese Subjects
The purpose of this study is to compare the bioavailability of two different formulations of lutikizumab, and to assess adverse events (AEs) and how lutikizumab moves through the body in healthy Chinese participants.
- Conditions
- Healthy Volunteers
- Being tested
- Lutikizumab Dose A, Lutikizumab Dose B
- Keywords
- Lutikizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutikizumab Dose ADrug
Injection; subcutaneous (SC)
Lutikizumab Dose BDrug
Injection; subcutaneous (SC)
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Dose A | Experimental | Participants will receive a single dose of Lutikizumab Dose A. Receives: Drug: Lutikizumab Dose A |
| Part 1, Dose B | Experimental | Participants will receive a single dose of Lutikizumab Dose B. Receives: Drug: Lutikizumab Dose B |
| Part 2 | Experimental | Han Chinese participants will receive a single dose of Lutikizumab. Receives: Drug: Lutikizumab Dose A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax) of Lutikizumab
Cmax of lutikizumab will be assessed.
Measured: Up to Day 8
Time to Cmax (Tmax) of Lutikizumab
Tmax of lutikizumab will be assessed.
Measured: Up to Day 8
Apparent Terminal Phase Elimination Rate Constant (β) of Lutikizumab
Apparent terminal phase elimination rate constant (β) of lutikizumab will be assessed.
Measured: Up to Day 8
Terminal Phase Elimination Half-life (t1/2) of Lutikizumab
Terminal phase elimination half-life (t1/2) of lutikizumab will be assessed.
Measured: Up to Day 8
Area under the Serum Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of Lutikizumab
AUC0-t of lutikizumab will be assessed.
Measured: Up to Day 8
AUC from Time 0 to Infinity (AUC0-inf) of Lutikizumab
AUC0-inf of lutikizumab will be assessed.
Measured: Up to Day 8
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 which does not necessarily have a causal relationship with this treatment.
Measured: Baseline to Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start28 Sep 2023
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
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
- None (open label)
- Enrolment
- 50 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
- NCT06067568
- Sponsor's protocol ID
- M24-465
- Status last verified
- Mar 2024
- First submitted
- 28 Sep 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. 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 Two Lutikizumab Formulations and to Evaluate Lutikizumab Pharmacokinetics, Safety, and Tolerability in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT06067568
- Acronym / sponsor ID
- M24-465
- Conditions
- Healthy Volunteers
- Keywords
- Lutikizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 5 Oct 2023 (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 purpose of this study is to compare the bioavailability of two different formulations of lutikizumab, and to assess adverse events (AEs) and how lutikizumab moves through the body in healthy Chinese participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1, Dose A | Experimental | Drug: Lutikizumab Dose AParticipants will receive a single dose of Lutikizumab Dose A. |
| Part 1, Dose B | Experimental | Drug: Lutikizumab Dose BParticipants will receive a single dose of Lutikizumab Dose B. |
| Part 2 | Experimental | Drug: Lutikizumab Dose AHan Chinese participants will receive a single dose of Lutikizumab. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female healthy volunteers aged between 18 and 60 years.
- -- Part 2 only: Participant must be first-generation Han Chinese of full Chinese parentage residing outside of China. Participant must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
- BMI <= 18.0 to <= 29.9 kg/m^2 after rounding to the tenths decimal, at screening and upon initial confinement.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG).
Key exclusion criteria (3 listed)
- Use 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 lutikizumab.
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 |
|---|---|---|
| Lutikizumab Dose AInjection; subcutaneous (SC) | Drug | Part 1, Dose A, Part 2 |
| Lutikizumab Dose BInjection; subcutaneous (SC) | Drug | Part 1, Dose B |
Primary outcome
Maximum Observed Serum Concentration (Cmax) of Lutikizumab
Time frame: Up to Day 8
Cmax of lutikizumab will be assessed.
Time to Cmax (Tmax) of Lutikizumab
Time frame: Up to Day 8
Tmax of lutikizumab will be assessed.
Apparent Terminal Phase Elimination Rate Constant (β) of Lutikizumab
Time frame: Up to Day 8
Apparent terminal phase elimination rate constant (β) of lutikizumab will be assessed.
Terminal Phase Elimination Half-life (t1/2) of Lutikizumab
Time frame: Up to Day 8
Terminal phase elimination half-life (t1/2) of lutikizumab will be assessed.
Area under the Serum Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of Lutikizumab
Time frame: Up to Day 8
AUC0-t of lutikizumab will be assessed.
AUC from Time 0 to Infinity (AUC0-inf) of Lutikizumab
Time frame: Up to Day 8
AUC0-inf of lutikizumab will be assessed.
Number of Participants with Adverse Events (AEs)
Time frame: Baseline to Day 71
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.
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 15 Mar 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
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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. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
3 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 Lutikizumab Dose A and Lutikizumab Dose B in people with Healthy Volunteers, run by AbbVie at 3 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 4 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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Serum Concentration (Cmax) of Lutikizumab (time frame: Up to Day 8). 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 15 Mar 2024.