A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers

A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Lpathomab Administered Intravenously to Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Biological: 0.5 mg/kg Lpathomab; Biological: 1.0 mg/kg Lpathomab; Biological: 3.0 mg/kg Lpathomab; Biological: 10 mg/kg Lpathomab; Biological: 20 mg/kg Lpathomab; Other: Saline solution for intravenous infusion

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • PRA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lpathomab; 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 Lpathomab; Biological: 1.0 mg/kg Lpathomab; Biological: 3.0 mg/kg Lpathomab; Biological: 10 mg/kg Lpathomab; Biological: 20 mg/kg Lpathomab
Placebo Comparator: Placebo; Saline solution for intravenous infusion	Other: Saline solution for intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with local or systemic Adverse Events	85 days

Collaborators and Investigators

• Sponsor: Lpath, Inc.
• Investigators: Study Director: Dario A Paggiarino, MD, Lpath, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimate): January 19, 2015

Study Record Updates

• Last Update Posted (Estimate): May 6, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: LT3114-NPP-001