PresbyopiaPhase 1/2NCT04403763
Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia
A Phase 1/2 study testing AGN-241622 in people with Presbyopia, run by AbbVie at 10 sites in United States.
Trial summary
The objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AGN-241622 ophthalmic solution for the first time in human participants Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- AGN-241622
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 10 sitesUnited States
- Study dates
- 27 Jul 2020to 5 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 65 at the time of study participation.
- Be a nonsmoker and nonuser of nicotine-containing products within the previous 1 year.
- Be able and willing to follow study instructions and complete all required study visits in the opinion of the study doctor.
Who cannot join
- History of alcohol or substance abuse within the 5 years prior to study participation.
- Enrollment in another investigational drug or device study within 30 days of study participation.
- Women who are pregnant, nursing, or planning a pregnancy during the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
PPD Clinical Research Unit - Austin /ID# 237644
Austin, Texas, 78744
United Medical Research Institute /ID# 234612
Inglewood, California, 90301
Global Research Foundation /ID# 237353
Los Angeles, California, 90041-1718
The Eye Care Institute /ID# 234507
Louisville, Kentucky, 40206
Total Eye Care, PA /ID# 234454
Memphis, Tennessee, 38119-5745
Quantum Clinical Trials /ID# 237330
Miami Beach, Florida, 33140
North Valley Eye Medical Group, Inc. /ID# 236686
Mission Hills, California, 91345-1200
The Eye Research Foundation /ID# 234526
Newport Beach, California, 92663-3637
Kannarr Eye Care /ID# 236718
Pittsburg, Kansas, 66762-2620
Eye associates /ID# 236502
San Antonio, Texas, 78229
About this study
Official title: A First-in-Human, Phase 1/2, Dose-ascending, Multicenter, Masked, Randomized, Vehicle-controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AGN-241622 in Healthy Participants and Participants With Presbyopia (Stage 1 and Stage 2) and Efficacy in Participants With Presbyopia (Stage 2)
The objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AGN-241622 ophthalmic solution for the first time in human participants
- Conditions
- Presbyopia
- Being tested
- AGN-241622, Vehicle
- Keywords
- Presbyopia,Healthy Subject,Subjects with Presbyopia
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-241622Drug
Topical eye drop
VehicleDrug
Topical eye drop
| Study group | Role | What they receive |
|---|---|---|
| Placebo Dose | Placebo comparator | Administered as single drop in one or both eyes Receives: Drug: Vehicle |
| Cohort 1: AGN-241622 Dose 1 (Low Dose) | Experimental | Administered as single drop in one eye Receives: Drug: AGN-241622 |
| Cohort 2: AGN-241622 Dose 2 (Medium Dose) | Experimental | Administered as single drop in one eye Receives: Drug: AGN-241622 |
| Cohort 3: AGN-241622 Dose 3 (High Dose) | Experimental | Administered as single drop in one eye Receives: Drug: AGN-241622 |
| Cohort 4: AGN-241622 Dose 1 (Low Dose) | Experimental | Administered as a single drop in each eye Receives: Drug: AGN-241622 |
| Cohort 5: AGN-241622 Dose 2 (Medium Dose) | Experimental | Administered as single drop in each eye Receives: Drug: AGN-241622 |
| Cohort 6: AGN-241622 Dose 3 (High Dose) | Experimental | Administered as single drop in each eye Receives: Drug: AGN-241622 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622
The number of participants who experience one or more TEAE during the treatment period
Measured: Up to 2 days
Stage 2a: Number of Patients Experiencing a Treatment Emergent Adverse Event After Repeat Administration of AGN-241622
The number of patients who experience one or more TEAE during the treatment period
Measured: 14 Days
Secondary outcomes (31)
Stage 1 Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1 Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants
Measured: Day 1
Stage 1: Pupil Diameter Measurement
To evaluate the target receptor engagement of AGN-241622 as compared with vehicle administered once, unilaterally in healthy participants
Measured: Day 1
Stage 2a Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Plasma Pharmacokinetics: Area Under the Plasma/Tear Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Plasma Pharmacokinetics: Minimum Plasma Concentrations (Cmin) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Plasma Pharmacokinetics: Accumulation Ratio of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Tears Pharmacokinetics: Area Under the Plasma/Tear Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Stage 2a Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start27 Jul 2020
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PresbyopiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT04403763
- Sponsor's protocol ID
- 2011-101-013
- Status last verified
- Jan 2024
- First submitted
- 1 May 2020
- Last updated
- 6 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Phase 1/2, Dose-ascending, Multicenter, Masked, Randomized, Vehicle-controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AGN-241622 in Healthy Participants and Participants With Presbyopia (Stage 1 and Stage 2) and Efficacy in Participants With Presbyopia (Stage 2)
- ClinicalTrials.gov ID
- NCT04403763
- Acronym / sponsor ID
- 2011-101-013
- Conditions
- Presbyopia
- Keywords
- Presbyopia,Healthy Subject,Subjects with Presbyopia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic considerations
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Posted 6 Feb 2024
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 evaluate the safety, tolerability, pharmacokinetics, and efficacy of AGN-241622 ophthalmic solution for the first time in human participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo Dose | Placebo comparator | Drug: VehicleAdministered as single drop in one or both eyes |
| Cohort 1: AGN-241622 Dose 1 (Low Dose) | Experimental | Drug: AGN-241622Administered as single drop in one eye |
| Cohort 2: AGN-241622 Dose 2 (Medium Dose) | Experimental | Drug: AGN-241622Administered as single drop in one eye |
| Cohort 3: AGN-241622 Dose 3 (High Dose) | Experimental | Drug: AGN-241622Administered as single drop in one eye |
| Cohort 4: AGN-241622 Dose 1 (Low Dose) | Experimental | Drug: AGN-241622Administered as a single drop in each eye |
| Cohort 5: AGN-241622 Dose 2 (Medium Dose) | Experimental | Drug: AGN-241622Administered as single drop in each eye |
| Cohort 6: AGN-241622 Dose 3 (High Dose) | Experimental | Drug: AGN-241622Administered as single drop in each eye |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40 to 65 at the time of study participation.
- Be a nonsmoker and nonuser of nicotine-containing products within the previous 1 year.
- Be able and willing to follow study instructions and complete all required study visits in the opinion of the study doctor.
Key exclusion criteria (3 listed)
- History of alcohol or substance abuse within the 5 years prior to study participation.
- Enrollment in another investigational drug or device study within 30 days of study participation.
- Women who are pregnant, nursing, or planning a pregnancy during the study.
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 |
|---|---|---|
| AGN-241622Topical eye drop | Drug | Cohort 1: AGN-241622 Dose 1 (Low Dose), Cohort 2: AGN-241622 Dose 2 (Medium Dose), Cohort 3: AGN-241622 Dose 3 (High Dose), Cohort 4: AGN-241622 Dose 1 (Low Dose), Cohort 5: AGN-241622 Dose 2 (Medium Dose), Cohort 6: AGN-241622 Dose 3 (High Dose) |
| VehicleTopical eye drop | Drug | Placebo Dose |
Primary outcome
Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622
Time frame: Up to 2 days
The number of participants who experience one or more TEAE during the treatment period
Stage 2a: Number of Patients Experiencing a Treatment Emergent Adverse Event After Repeat Administration of AGN-241622
Time frame: 14 Days
The number of patients who experience one or more TEAE during the treatment period
31 secondary outcomes
Stage 1 Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
Time frame: Day 1
Stage 1 Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
Time frame: Day 1
Stage 1 Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
Time frame: Day 1
Stage 1 Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
Time frame: Day 1
Stage 1 Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)
Time frame: Day 1
Stage 1 Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622
Time frame: Day 1
Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
Time frame: Day 1
Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622
Time frame: Day 1
Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
Time frame: Day 1
Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622
Time frame: Day 1
Stage 1 Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
Time frame: Day 1
Stage 1 Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
Time frame: Day 1
Stage 1 Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
Time frame: Day 1
Stage 1 Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
Time frame: Day 1
Stage 1: Pupil Diameter Measurement
Time frame: Day 1
Stage 2a Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
Time frame: 14 Days
Stage 2a Plasma Pharmacokinetics: Area Under the Plasma/Tear Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of AGN-241622
Time frame: 14 Days
Stage 2a Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
Time frame: 14 Days
Stage 2a Plasma Pharmacokinetics: Minimum Plasma Concentrations (Cmin) of AGN-241622
Time frame: 14 Days
Stage 2a Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
Time frame: 14 Days
Stage 2a Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
Time frame: 14 Days
Stage 2a Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
Time frame: 14 Days
Stage 2a Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)
Time frame: 14 Days
Stage 2a Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622
Time frame: 14 Days
Stage 2a Plasma Pharmacokinetics: Accumulation Ratio of AGN-241622
Time frame: 14 Days
Stage 2a Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622
Time frame: 14 Days
Stage 2a Tears Pharmacokinetics: Area Under the Plasma/Tear Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of AGN-241622
Time frame: 14 Days
Stage 2a Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
Time frame: 14 Days
Stage 2a Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
Time frame: 14 Days
Stage 2a Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
Time frame: 14 Days
Stage 2a Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
Time frame: 14 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AGN-241622 in people with Presbyopia, run by AbbVie at 10 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 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: stopped early, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622 (time frame: Up to 2 days). The study lists 2 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 6 Feb 2024.