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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02341508
• Other study ID #: LT3114-NPP-001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: January 7, 2015
• Last updated: February 1, 2016
• Start date: September 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2016
• Source: Lpath, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Biological:
• 0.5 mg/kg Lpathomab

• 1.0 mg/kg Lpathomab

• 3.0 mg/kg Lpathomab

• 10 mg/kg Lpathomab

• 20 mg/kg Lpathomab

Other:
• Saline solution for intravenous infusion

Locations

Country	Name	City	State
United States	PRA Health Sciences	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Lpath, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with local or systemic Adverse Events		85 days	Yes