First-in-Human Study of LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration

NCT02076919 | Completed Phase 1 Results

• 1 other identifier: C-13-007
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this first-in-human study is to assess the local ocular and systemic safety and tolerability of LHA510 eye drops when administered at various concentrations and dosing frequencies.

Conditions

Age-Related Macular Degeneration

Keywords

LHA510; First in human; Safety; Tolerability; Pharmacokinetics; Elderly; Age-Related Macular Degeneration; AMD; Ocular; Eye drop

Outcome Measures

Primary Outcomes (4)

• Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1

  A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.

  From time of consent until 30 days after stopping the trial/study drug

• Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 2

  A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.

  From time of consent until 30 days after stopping the trial/study drug

• Number of Subjects Experiencing a Non-serious Adverse Event, Part I

  An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.

  From time of consent until 30 days after stopping the trial/study drug

• Number of Subjects Experiencing a Non-serious Adverse Event, Part 2

  An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.

  From time of consent until 30 days after stopping the trial/study drug

Secondary Outcomes (10)

• The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration [Mass / Volume] (Cmax), Part 2

  Up to Day 15

• The Time to Reach the Maximum Concentration After Drug Administration [Time] (Tmax), Part 2

  Up to Day 15

• The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [Mass x Time/Volume] (AUClast), Part 2

  Up to Day 15

• The Terminal Elimination Half-life [Time] (T1/2), Part 2

  Up to Day 15

• Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1

  Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose

Study Arms (4)

LHA510 Part 1

EXPERIMENTAL

LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1

Drug: LHA510 Ophthalmic Suspension

LHA510 Vehicle Part 1

PLACEBO COMPARATOR

Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1

Drug: LHA510 Vehicle

LHA510 Part 2

EXPERIMENTAL

LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2

Drug: LHA510 Ophthalmic Suspension

LHA510 Vehicle Part 2

PLACEBO COMPARATOR

Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2

Drug: LHA510 Vehicle

Interventions

LHA510 Ophthalmic Suspension DRUG

Ophthalmic suspension in 4 concentration levels topically administered in Part 1 and Part 2

LHA510 Part 1; LHA510 Part 2

LHA510 Vehicle DRUG

Inactive ingredients used for masking purposes

LHA510 Vehicle Part 1; LHA510 Vehicle Part 2

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent.
• Vital signs within the following ranges:
• oral body temperature between 35.0-37.5 °C
• systolic blood pressure, 90-150 mm Hg
• diastolic blood pressure, 50-90 mm Hg
• pulse rate, 40 - 100 bpm.
• Weigh at least 50 kg.
• Able to communicate well with the investigator.
• Able to understand and comply with the requirements of the study.
• Additional eligibility criteria for Part 2 (AMD subjects):
• Evidence of AMD in one or both eyes.
• Age 55-90.

You may not qualify if:

• Any currently active ocular condition that requires use of topical eye drops.
• Use of contact lens over the course of the study.
• Abnormal corneal examination results at screening or eligibility.
• History of any ocular surgery within the past 6 months prior to study participation.
• Use of other investigational drugs within 30 days of enrollment.
• History of hypersensitivity or allergy to any of the study drugs (including fluorescein) or to drugs of similar chemical classes.
• History of clinically significant ECG abnormalities, or any ECG abnormality at screening or eligibility.
• Known history or current clinically significant arrhythmias.
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential.
• Use of any prohibited medication as specified in the protocol.
• Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing.
• Low hemoglobin levels at screening or eligibility as specified in the protocol.
• Significant illness as specified in the protocol.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Macular Degeneration

Interventions

acrizanib

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Principal Clinical Scientist, CA CSI ID
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Robert Maietta, BSc

  Alcon Research

  STUDY DIRECTOR

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: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 4, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 1, 2016
• Results First Posted: September 4, 2015

Record last verified: 2016-03