A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers
NCT ID: NCT02341508
Last Updated: 2016-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2015-09-30
2016-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of LY3025876 in Healthy Volunteers
NCT01528124
A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants
NCT03841630
A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants
NCT04178733
Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study of SKL24741 in Healthy Subjects
NCT04505397
A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants
NCT04503603
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lpathomab
0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab, 3.0 mg/kg Lpathomab, 10 mg/kg 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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
0.5 mg/kg Lpathomab
1.0 mg/kg Lpathomab
3.0 mg/kg Lpathomab
10 mg/kg Lpathomab
20 mg/kg Lpathomab
Saline solution for intravenous infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lpath, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dario A Paggiarino, MD
Role: STUDY_DIRECTOR
Lpath, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
PRA Health Sciences
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LT3114-NPP-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.