Study Stopped
Strategic considerations
Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia
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)
1 other identifier
interventional
80
1 country
10
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2020
Typical duration for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedStudy Start
First participant enrolled
July 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2022
CompletedResults Posted
Study results publicly available
February 6, 2024
CompletedFebruary 6, 2024
January 1, 2024
2.4 years
May 1, 2020
December 4, 2023
January 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
14 Days
Secondary Outcomes (31)
Stage 1 Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622
Day 1
Stage 1 Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622
Day 1
Stage 1 Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622
Day 1
Stage 1 Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622
Day 1
Stage 1 Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F)
Day 1
- +26 more secondary outcomes
Study Arms (7)
Placebo Dose
PLACEBO COMPARATORAdministered as single drop in one or both eyes
Cohort 1: AGN-241622 Dose 1 (Low Dose)
EXPERIMENTALAdministered as single drop in one eye
Cohort 2: AGN-241622 Dose 2 (Medium Dose)
EXPERIMENTALAdministered as single drop in one eye
Cohort 3: AGN-241622 Dose 3 (High Dose)
EXPERIMENTALAdministered as single drop in one eye
Cohort 4: AGN-241622 Dose 1 (Low Dose)
EXPERIMENTALAdministered as a single drop in each eye
Cohort 5: AGN-241622 Dose 2 (Medium Dose)
EXPERIMENTALAdministered as single drop in each eye
Cohort 6: AGN-241622 Dose 3 (High Dose)
EXPERIMENTALAdministered as single drop in each eye
Interventions
Topical eye drop
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (10)
United Medical Research Institute /ID# 234612
Inglewood, California, 90301, United States
Global Research Foundation /ID# 237353
Los Angeles, California, 90041-1718, United States
North Valley Eye Medical Group, Inc. /ID# 236686
Mission Hills, California, 91345-1200, United States
The Eye Research Foundation /ID# 234526
Newport Beach, California, 92663-3637, United States
Quantum Clinical Trials /ID# 237330
Miami Beach, Florida, 33140, United States
Kannarr Eye Care /ID# 236718
Pittsburg, Kansas, 66762-2620, United States
The Eye Care Institute /ID# 234507
Louisville, Kentucky, 40206, United States
Total Eye Care, PA /ID# 234454
Memphis, Tennessee, 38119-5745, United States
PPD Clinical Research Unit - Austin /ID# 237644
Austin, Texas, 78744, United States
Eye associates /ID# 236502
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2020
First Posted
May 27, 2020
Study Start
July 27, 2020
Primary Completion
December 5, 2022
Study Completion
December 5, 2022
Last Updated
February 6, 2024
Results First Posted
February 6, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.