Healthy SubjectsPhase 1NCT02341508
A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers
A Phase 1 study testing 0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab and 3.0 mg/kg Lpathomab in people with Healthy Subjects, run by Lpath, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- 0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab and 3.0 mg/kg Lpathomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Subjects
- Being tested
- 0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab, 3.0 mg/kg Lpathomab, 10 mg/kg Lpathomab, 20 mg/kg Lpathomab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 mg/kg LpathomabBiological
1.0 mg/kg LpathomabBiological
3.0 mg/kg LpathomabBiological
10 mg/kg LpathomabBiological
20 mg/kg LpathomabBiological
Saline solution for intravenous infusionOther
| Study group | Role | What they receive |
|---|---|---|
| Lpathomab | Experimental | 0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab, 3.0 mg/kg Lpathomab, 10 mg/kg Lpathomab, 20 mg/kg Lpathomab, Receives: 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 |
| Placebo | Placebo comparator | Saline solution for intravenous infusion Receives: Other: Saline solution for intravenous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with local or systemic Adverse Events
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lpath, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dario A Paggiarino, MD, Study director, Lpath, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341508
- Sponsor's protocol ID
- LT3114-NPP-001
- Status last verified
- May 2016
- First submitted
- 7 Jan 2015
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02341508
- Acronym / sponsor ID
- LT3114-NPP-001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Lpath, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lpathomab | Experimental | 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 Lpathomab0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab, 3.0 mg/kg Lpathomab, 10 mg/kg Lpathomab, 20 mg/kg Lpathomab, |
| Placebo | Placebo comparator | Other: Saline solution for intravenous infusionSaline solution for intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5 mg/kg Lpathomab | Biological | Lpathomab |
| 1.0 mg/kg Lpathomab | Biological | Lpathomab |
| 3.0 mg/kg Lpathomab | Biological | Lpathomab |
| 10 mg/kg Lpathomab | Biological | Lpathomab |
| 20 mg/kg Lpathomab | Biological | Lpathomab |
| Saline solution for intravenous infusion | Other | Placebo |
Primary outcome
Proportion of patients with local or systemic Adverse Events
Time frame: 85 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dario A Paggiarino, MD study director
Lpath, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.5 mg/kg Lpathomab, 1.0 mg/kg Lpathomab and 3.0 mg/kg Lpathomab in people with Healthy Subjects, run by Lpath, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with local or systemic Adverse Events (time frame: 85 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.