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)

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 Overview

• Status: Terminated
• Conditions: Presbyopia
• Intervention / Treatment: Drug: AGN-241622; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • California
    • Inglewood, California, United States, 90301
      • United Medical Research Institute /ID# 234612
    • Los Angeles, California, United States, 90041-1718
      • Global Research Foundation /ID# 237353
    • Mission Hills, California, United States, 91345-1200
      • North Valley Eye Medical Group, Inc. /ID# 236686
    • Newport Beach, California, United States, 92663-3637
      • The Eye Research Foundation /ID# 234526
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Quantum Clinical Trials /ID# 237330
  • Kansas
    • Pittsburg, Kansas, United States, 66762-2620
      • Kannarr Eye Care /ID# 236718
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • The Eye Care Institute /ID# 234507
  • Tennessee
    • Memphis, Tennessee, United States, 38119-5745
      • Total Eye Care, PA /ID# 234454
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Clinical Research Unit - Austin /ID# 237644
    • San Antonio, Texas, United States, 78229
      • Eye associates /ID# 236502

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Dose; Administered as single drop in one or both eyes	Drug: Vehicle; Topical eye drop
Experimental: Cohort 1: AGN-241622 Dose 1 (Low Dose); Administered as single drop in one eye	Drug: AGN-241622; Topical eye drop
Experimental: Cohort 2: AGN-241622 Dose 2 (Medium Dose); Administered as single drop in one eye	Drug: AGN-241622; Topical eye drop
Experimental: Cohort 3: AGN-241622 Dose 3 (High Dose); Administered as single drop in one eye	Drug: AGN-241622; Topical eye drop
Experimental: Cohort 4: AGN-241622 Dose 1 (Low Dose); Administered as a single drop in each eye	Drug: AGN-241622; Topical eye drop
Experimental: Cohort 5: AGN-241622 Dose 2 (Medium Dose); Administered as single drop in each eye	Drug: AGN-241622; Topical eye drop
Experimental: Cohort 6: AGN-241622 Dose 3 (High Dose); Administered as single drop in each eye	Drug: AGN-241622; Topical eye drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	14 Days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): December 5, 2022

Study Registration Dates

• First Submitted: May 1, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Presbyopia,Healthy Subject,Subjects with Presbyopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: 2011-101-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing 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/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No