A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers
Status: | Active, not recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2015 |
End Date: | April 2016 |
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
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.
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.
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.
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