NCT02341508

Brief Summary

The primary purpose of this study is to evaluate the safety and tolerability of Lpathomab in healthy volunteers. Additional endpoints include characterization of the pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity profiles of a single IV dose of Lpathomab in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

January 7, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

January 7, 2015

Last Update Submit

May 4, 2016

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with local or systemic Adverse Events

    85 days

Study Arms (2)

Lpathomab

EXPERIMENTAL

0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab, 3.0 mg/kg Lpathomab, 10 mg/kg Lpathomab, 20 mg/kg Lpathomab,

Biological: 0.5 mg/kg LpathomabBiological: 1.0 mg/kg LpathomabBiological: 3.0 mg/kg LpathomabBiological: 10 mg/kg LpathomabBiological: 20 mg/kg Lpathomab

Placebo

PLACEBO COMPARATOR

Saline solution for intravenous infusion

Other: Saline solution for intravenous infusion

Interventions

0.5 mg/kg LpathomabBIOLOGICAL
Lpathomab
10 mg/kg LpathomabBIOLOGICAL
Lpathomab
3.0 mg/kg LpathomabBIOLOGICAL
Lpathomab
20 mg/kg LpathomabBIOLOGICAL
Lpathomab
Saline solution for intravenous infusionOTHER
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female subject ≥ 18 years old between 50 and 145 kg
  • Laboratory values and ECG during Screening period within normal range or evaluated as not clinically significant (NCS)
  • Female subjects must be not of child-bearing potential or using double-barrier method of contraception
  • Male subjects must use double-barrier contraception during the study period
  • Subject is able to read, understand, and sign the informed consent form (ICF) and HIPAA release

You may not qualify if:

  • Subjects with diabetes mellitus (glycated hemoglobin \[HbA1c\]≥6.5%) or pre-diabetes mellitus (HbA1c between 5.7 and 6.4%).
  • Male subjects with corrected Q-T interval (QTc)\> 450 msec or a QRS interval\>120 msec and female subjects with QTc\> 470 or a QRS interval\>120 msec.
  • Subject's blood pressure (BP) during screening period exceeds 140/90 mm Hg
  • Subject is positive for HIV, hep B and/or hep C at screening
  • Subject has significant psychiatric co-morbidity including but not limited to major depression-severe, bipolar disorder or schizophrenia spectrum disorder, history of suicide attempt, or active suicidal ideation in 6 months prior to screen.
  • Subject has any significant or advanced systemic illness, unstable or severe medical condition(s) or end stage disease that could put them at risk during the study, interfere with outcome measures, or affect compliance with the protocol procedures and requirements.
  • Subject has history of cancer stability/remission for less than 5 years, with the exception of non-metastatic basal and/or squamous cell carcinomas of the skin and cervical cancer in situ.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA Health Sciences

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Interventions

Saline SolutionInfusions, Intravenous

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAdministration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, Parenteral

Study Officials

  • Dario A Paggiarino, MD

    Lpath, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 19, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 6, 2016

Record last verified: 2016-05

Locations

US(1)