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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02341508

Enrollment

Registered

2015-01-19

Start date

2015-09-30

Completion date

2016-03-31

Last updated

2016-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

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.

Interventions

BIOLOGICAL0.5 mg/kg Lpathomab

BIOLOGICAL1.0 mg/kg Lpathomab

BIOLOGICAL3.0 mg/kg Lpathomab

BIOLOGICAL10 mg/kg Lpathomab

BIOLOGICAL20 mg/kg Lpathomab

OTHERSaline solution for intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026