Phase 1
Completed N=80
First-in-Human Study of LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration
Source: ClinicalTrials.gov NCT02076919 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1 — 0; 0; 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1 |
0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 2 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Experiencing a Non-serious Adverse Event, Part I |
2; 1; 0; 1; 1 | — |
| PRIMARY Number of Subjects Experiencing a Non-serious Adverse Event, Part 2 |
3; 1; 1; 2; 2; 1 | — |
| SECONDARY The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration [Mass / Volume] (Cmax), Part 2 |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY The Time to Reach the Maximum Concentration After Drug Administration [Time] (Tmax), Part 2 |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY 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 |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY The Terminal Elimination Half-life [Time] (T1/2), Part 2 |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1 |
5.2; -5.5; 2.8; 4.1; -5.2; 3.4 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1 |
4.7; 0.5; 0.5; 5.3; 0.2; -1.3 | — |
| SECONDARY Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1 |
5.2; -4.4; 2.4; 4.7; -3.4; 2.0 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2 |
-1.0; -4.4; -0.6; -2.9; 2.5; 0.6 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2 |
12.5; -11.1; -4.1; -4.8; 0.6; -4.1 | — |
| SECONDARY Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2 |
3.5; -6.8; -1.7; -3.5; 1.9; -1.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- 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.
- History of drug or alcohol abuse within the 12 months prior to dosing.
Additional exclusion criteria for Part 1 (healthy subjects):
- Abnormal thickness of the central retinal subfield on OCT at screening.
- History of any chronic eye disease other than refractive error, incipient cataract, strabismic amblyopia, or anisometropic amblyopia.
Additional exclusion criteria for Part 2 (AMD subjects):
- Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab (Lucentis®), aflibercept (Eylea®), bevacizumab (Avastin®), pegaptanib (Macugen®), or any other VEGF inhibitor.
- Patients who have required and received regular monthly injections of these drugs in the months preceding the study.
Data sourced from ClinicalTrials.gov (NCT02076919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.