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

Lpath

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Biological: 1.0 mg/kg Lpathomab; Biological: 3.0 mg/kg Lpathomab; Biological: 10 mg/kg Lpathomab; Biological: 20 mg/kg Lpathomab; Biological: 0.5 mg/kg Lpathomab; Other: Saline solution for intravenous infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02341508

LT3114-NPP-001

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Lpathomab

Experimental group

Description:

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

Treatment:

Biological: 10 mg/kg Lpathomab

Biological: 3.0 mg/kg Lpathomab

Biological: 1.0 mg/kg Lpathomab

Biological: 0.5 mg/kg Lpathomab

Biological: 20 mg/kg Lpathomab

Placebo

Placebo Comparator group

Description:

Saline solution for intravenous infusion

Treatment:

Other: Saline solution for intravenous infusion