Healthy VolunteerPhase 1NCT06698926
A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants
A Phase 1 study testing ABBV-CLS-616 and Itraconazole in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
This is a Phase 1, first in human, randomized, four-part study to investigate the safety, tolerability, and pharmacokinetics of ABBV-CLS-616 after oral dosing in healthy 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-CLS-616 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 9 Jan 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 2 only: Participant must have normal platelet count at screening and upon initial confinement.
- Part 2 only: Participant must not have known or suspected coagulopathy, or prothrombin time (PT)/activated partial thromboplastin time (aPTT)/international normalized ratio (INR) values outside of normal range at screening.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, neurological examination, ophthalmic examination (Part 2 only) laboratory profile and a 12-lead Electrocardiogram.
Who cannot join
- Part 2 only: Clinically significant active or recurrent ocular disease.
- Part 2 only: History of lumbar puncture and/or collection of cerebrospinal fluid within 30 days prior to Screening.
- Part 2 only: History of current condition of chronic lower back pain.
- Evidence of conditions that might preclude the subject from undergoing a lumbar puncture.
- History of clinically significant neurological epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, coagulopathy, or any uncontrolled medical illness.
- History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale completed at Screening, or any history of suicide attempts within the last two years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 First in Human, Single and Multiple Ascending Dose, Food Effect, and Drug-Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-CLS-616
This is a Phase 1, first in human, randomized, four-part study to investigate the safety, tolerability, and pharmacokinetics of ABBV-CLS-616 after oral dosing in healthy volunteers.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-CLS-616, Placebo, Itraconazole
- Keywords
- Healthy Volunteer, ABBV-CLS-616
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-CLS-616Drug
Oral Tablet
PlaceboDrug
Oral Tablet
ItraconazoleDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Group 1 | Experimental | Participants will receive either ABBV-CLS-616 Dose A or placebo after fasting on Day 1 and will be confined for 19 days. Receives: Drug: ABBV-CLS-616; Drug: Placebo |
| Part 1: Group 2 | Experimental | Participants will receive either ABBV-CLS-616 Dose B or placebo after fasting on Day 1 and will be confined for 19 days. Receives: Drug: ABBV-CLS-616; Drug: Placebo |
| Part 1: Group 3 | Experimental | Participants will receive either ABBV-CLS-616 Dose C or placebo after fasting on Day 1 and will be confined for 8 days. Receives: Drug: ABBV-CLS-616; Drug: Placebo |
| Part 1: Group 4 | Experimental | Participants will receive either ABBV-CLS-616 Dose D or placebo after fasting on Day 1 and will be confined for 8 days. Receives: Drug: ABBV-CLS-616; Drug: Placebo |
| Part 1: Group 5 | Experimental | Participants will receive either ABBV-CLS-616 Dose E or placebo after fasting on Day 1 and will be confined for 8 days. Receives: Drug: ABBV-CLS-616; Drug: Placebo |
| Part 1: Group 6 | Experimental | Participants will receive either ABBV-CLS-616 Dose F or placebo after fasting on Day 1 and will be confined for 8 days. Receives: Drug: ABBV-CLS-616; Drug: Placebo |
| Part 2: Group 7 | Experimental | Participants will receive either ABBV-CLS-616 Dose G or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. Receives: Drug: ABBV-CLS-616; Drug: Placebo |
| Part 2: Group 8 | Experimental | Participants will receive either ABBV-CLS-616 Dose H or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. Receives: Drug: ABBV-CLS-616; Drug: Placebo |
| Part 2: Group 9 | Experimental | Participants will receive either ABBV-CLS-616 Dose D or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. Receives: Drug: ABBV-CLS-616; Drug: Placebo |
| Part 2: Group 10 | Experimental | Participants will receive either ABBV-CLS-616 Dose E or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. Receives: Drug: ABBV-CLS-616; Drug: Placebo |
| Part 2: Group 11 | Experimental | Participants will receive either ABBV-CLS-616 Dose F or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. Receives: Drug: ABBV-CLS-616; Drug: Placebo |
| Part 3: Sequence 1 | Experimental | In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 after fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, without fasting and will be confined for 8 days. Receives: Drug: ABBV-CLS-616 |
| Part 3: Sequence 2 | Experimental | In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 without fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 8 days. Receives: Drug: ABBV-CLS-616 |
| Part 4: Itraconazole | Experimental | In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 7 days. In Period 2, participants will receive Itraconazole daily for 10 days without fasting and will receive ABBV-CLS-616 Dose C on Day 4 after fasting. Participants will be confined for 11 days. Receives: Drug: ABBV-CLS-616; Drug: Itraconazole |
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 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start11 Nov 2024
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Calico Life Sciences LLC
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698926
- Sponsor's protocol ID
- M25-206
- Status last verified
- Jan 2026
- First submitted
- 6 Nov 2024
- Last updated
- 15 Jan 2026
- 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 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First in Human, Single and Multiple Ascending Dose, Food Effect, and Drug-Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-CLS-616
- ClinicalTrials.gov ID
- NCT06698926
- Acronym / sponsor ID
- M25-206
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-CLS-616
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Calico Life Sciences LLC
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 21 Nov 2024 (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 is a Phase 1, first in human, randomized, four-part study to investigate the safety, tolerability, and pharmacokinetics of ABBV-CLS-616 after oral dosing in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part 1: Group 1 | Experimental | Drug: ABBV-CLS-616, Drug: PlaceboParticipants will receive either ABBV-CLS-616 Dose A or placebo after fasting on Day 1 and will be confined for 19 days. |
| Part 1: Group 2 | Experimental | Drug: ABBV-CLS-616, Drug: PlaceboParticipants will receive either ABBV-CLS-616 Dose B or placebo after fasting on Day 1 and will be confined for 19 days. |
| Part 1: Group 3 | Experimental | Drug: ABBV-CLS-616, Drug: PlaceboParticipants will receive either ABBV-CLS-616 Dose C or placebo after fasting on Day 1 and will be confined for 8 days. |
| Part 1: Group 4 | Experimental | Drug: ABBV-CLS-616, Drug: PlaceboParticipants will receive either ABBV-CLS-616 Dose D or placebo after fasting on Day 1 and will be confined for 8 days. |
| Part 1: Group 5 | Experimental | Drug: ABBV-CLS-616, Drug: PlaceboParticipants will receive either ABBV-CLS-616 Dose E or placebo after fasting on Day 1 and will be confined for 8 days. |
| Part 1: Group 6 | Experimental | Drug: ABBV-CLS-616, Drug: PlaceboParticipants will receive either ABBV-CLS-616 Dose F or placebo after fasting on Day 1 and will be confined for 8 days. |
| Part 2: Group 7 | Experimental | Drug: ABBV-CLS-616, Drug: PlaceboParticipants will receive either ABBV-CLS-616 Dose G or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 2: Group 8 | Experimental | Drug: ABBV-CLS-616, Drug: PlaceboParticipants will receive either ABBV-CLS-616 Dose H or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 2: Group 9 | Experimental | Drug: ABBV-CLS-616, Drug: PlaceboParticipants will receive either ABBV-CLS-616 Dose D or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 2: Group 10 | Experimental | Drug: ABBV-CLS-616, Drug: PlaceboParticipants will receive either ABBV-CLS-616 Dose E or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 2: Group 11 | Experimental | Drug: ABBV-CLS-616, Drug: PlaceboParticipants will receive either ABBV-CLS-616 Dose F or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 3: Sequence 1 | Experimental | Drug: ABBV-CLS-616In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 after fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, without fasting and will be confined for 8 days. |
| Part 3: Sequence 2 | Experimental | Drug: ABBV-CLS-616In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 without fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 8 days. |
| Part 4: Itraconazole | Experimental | Drug: ABBV-CLS-616, Drug: ItraconazoleIn Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 7 days. In Period 2, participants will receive Itraconazole daily for 10 days without fasting and will receive ABBV-CLS-616 Dose C on Day 4 after fasting. Participants will be confined for 11 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Part 2 only: Participant must have normal platelet count at screening and upon initial confinement.
- Part 2 only: Participant must not have known or suspected coagulopathy, or prothrombin time (PT)/activated partial thromboplastin time (aPTT)/international normalized ratio (INR) values outside of normal range at screening.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, neurological examination, ophthalmic examination (Part 2 only) laboratory profile and a 12-lead Electrocardiogram.
Key exclusion criteria (6 listed)
- Part 2 only: Clinically significant active or recurrent ocular disease.
- Part 2 only: History of lumbar puncture and/or collection of cerebrospinal fluid within 30 days prior to Screening.
- Part 2 only: History of current condition of chronic lower back pain.
- Evidence of conditions that might preclude the subject from undergoing a lumbar puncture.
- History of clinically significant neurological epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, coagulopathy, or any uncontrolled medical illness.
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-CLS-616Oral Tablet | Drug | Part 1: Group 1, Part 1: Group 2, Part 1: Group 3, Part 1: Group 4, Part 1: Group 5, Part 1: Group 6, Part 2: Group 10, Part 2: Group 11, Part 2: Group 7, Part 2: Group 8, Part 2: Group 9, Part 3: Sequence 1, Part 3: Sequence 2, Part 4: Itraconazole |
| PlaceboOral Tablet | Drug | Part 1: Group 1, Part 1: Group 2, Part 1: Group 3, Part 1: Group 4, Part 1: Group 5, Part 1: Group 6, Part 2: Group 10, Part 2: Group 11, Part 2: Group 7, Part 2: Group 8, Part 2: Group 9 |
| ItraconazoleOral Capsule | Drug | Part 4: Itraconazole |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 90 days
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.
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 Jan 2026.
- Individual participant dataSharing planned: No
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Healthy Participants
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
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-CLS-616 and Itraconazole in people with Healthy Volunteer, 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 3 inclusion and 6 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 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?
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?
Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 90 days). 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 Jan 2026.