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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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