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

Phase 1

Completed

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

• Registration Number: NCT02341508
• Lead Sponsor: Lpath, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-19
• Study Start: 2015-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-04
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lpathomab	0.5 mg/kg Lpathomab	0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab, 3.0 mg/kg Lpathomab, 10 mg/kg Lpathomab, 20 mg/kg Lpathomab,
Lpathomab	1.0 mg/kg Lpathomab	0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab, 3.0 mg/kg Lpathomab, 10 mg/kg Lpathomab, 20 mg/kg Lpathomab,
Lpathomab	20 mg/kg Lpathomab	0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab, 3.0 mg/kg Lpathomab, 10 mg/kg Lpathomab, 20 mg/kg Lpathomab,
Placebo	Saline solution for intravenous infusion	Saline solution for intravenous infusion
Lpathomab	3.0 mg/kg Lpathomab	0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab, 3.0 mg/kg Lpathomab, 10 mg/kg Lpathomab, 20 mg/kg Lpathomab,
Lpathomab	10 mg/kg Lpathomab	0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab, 3.0 mg/kg Lpathomab, 10 mg/kg Lpathomab, 20 mg/kg Lpathomab,

Primary Outcome Measures

Name	Time	Method
Proportion of patients with local or systemic Adverse Events	85 days

Trial Locations

Locations (1)

PRA Health Sciences; 🇺🇸 Salt Lake City, Utah, United States