PneumoniaPhase 1NCT02724085
A Phase 1 Study to Assess the Safety, Tolerability and PK of IV TP-271
A Phase 1 study testing TP-271 in people with Pneumonia, run by Tetraphase Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This is a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose, inpatient study to assess the safety, tolerability, and pharmacokinetics of TP-271 in healthy subjects. Subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- TP-271
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2015to 12 Dec 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be within the age range of 18 to 50 years, inclusive, at the time of Screening.
- Voluntarily sign an IRB/Research Ethics Committee (IRB/REC)-approved ICF to participate in the study after all relevant aspects of the study have been explained and discussed with the subject and before undergoing any study related procedures.
- Have a body mass index (BMI) ≥18.0 and ≤33.0 kg/m2.
- Be clear of any history of, and have negative screen for, HIV 1 and 2 and hepatitis B and C.
- Have the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
- Females must be of non-child bearing potential, either 1-year post-menopausal or surgically sterile (bilateral oophorectomy, bilateral tubal ligation, or complete hysterectomy).
- Male subjects must be willing and able to use a barrier method of birth control or practice abstinence (even if they have had a vasectomy) from dosing through 90 days after the dose of IMP.
Who cannot join
- History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, and psychiatric/mental disease/disorders, which, in the opinion of the PI, may either put the subject at risk because of participation in the study, influence the results of the study, or influence the subject's ability to participate in the study.
- Clinical laboratory values that fall outside the eligibility range specified in the table in Appendix C are exclusionary. For the laboratory values that are not included in Appendix C, values outside of the reference range are exclusionary with the following exceptions:
- Low Chemistry Values High Chemistry Values Out of Range UA Out of Range Hematology Bicarbonate (> 18 mEq/L Chloride GGT HDL Cholesterol LDH LDL Cholesterol Phosphorus Triglycerides Chloride HDL Cholesterol LDL Cholesterol Phosphorus Triglycerides High or low specific gravity Cloudy Mucus Crystals Ketones (when blood glucose is normal) Hyaline casts High or low pH
- High hematocrit Basophils Monocytes MCV MCHC MCH RBC
- Blood pressure and pulse outside of the following ranges are exclusionary:
- Systolic blood pressure 85 - 145 mm Hg
Show all 27Show fewer
- Diastolic blood pressure 50 - 95 mm Hg
- Pulse rate 45 - 95 beats per minute (bpm)
- Known allergy to tetracycline antibiotics or to any of the excipients in TP-271.
- Clinically significant abnormal 12-lead ECG, including the following:
- Rhythm other than sinus, QTc interval using Fridericia's formula (QTcF) >450 msec;
- Evidence of second- or third-degree atrioventricular (AV) block;
- Pathological Q-waves (defined as Q-wave >40 msec or depth >0.4 to 0.5 mV);
- Evidence of ventricular pre-excitation;
- Electrocardiographic evidence of complete left bundle branch block, right bundle branch block (RBBB), incomplete LBBB;
- Intraventricular conduction delay with QRS duration >120 msec;
- ST segment abnormalities unless judged by the Investigator to be non-pathologic.
- History of seizures.
- A history within 3 years of Screening of drug abuse (including benzodiazepines, opioids, amphetamine, and cocaine) or a positive drug result at Screening for any of these drugs of abuse. Also excluded are subjects who test positive for cannabinoids (THCs).
- Use of tobacco, nicotine, or nicotine-replacement products within the 3 months prior to the dose of study drug through the last study visit.
- Typical weekly alcohol consumption of 7 or more alcoholic drinks. One drink is defined as 1 glass of beer (approximately 10 to 12 oz) or 1 can (12 oz) of beer, 1 glass of wine (approximately 4 to 5 oz), or 1 glass of distilled spirits (hard liquor) containing 1 oz of the liquor (1 oz of liquid is approximately 30 mL).
- Alcohol consumption within 48 hours prior to dosing.
- Participation in a clinical trial within 10 half-lives of the prior study treatment or the past 3 months if the half-life is unknown of dose or planned participation in another trial in addition to this one during the trial.
- History of difficulty in donating blood or poor venous access.
- Subject has donated blood (1 unit or 350 mL) within 1 month prior to receiving test material or plans to donate prior to receiving test material or during the trial.
- Use of any prescription or non-prescription medication, including vitamins or herbal medications, within 7 days, or 5 half-lives (if known), whichever is longer, prior to dosing. The use of acetaminophen, naproxen, and ibuprofen is permitted except for within 24 hours prior to dosing. (Note: Subjects must refrain from taking herbal or dietary supplements or prescription drug therapy for the duration of the study.)
- Unwillingness or inability to follow the procedures outlined in the protocol. Subject is mentally or legally incapacitated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous TP-271 in Healthy Adult Subjects
This is a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose, inpatient study to assess the safety, tolerability, and pharmacokinetics of TP-271 in healthy subjects. Subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study.
Read the detailed description
Up to seven cohorts of eight subjects each (up to a total of 56 subjects) will be enrolled. The eight subjects within each cohort will be randomized 6:2 to receive a single intravenous dose of TP-271 or placebo. The planned doses are:
Cohort A: 0.15 mg/kg Cohort B: 0.45 mg/kg Cohort C: 1.0 mg/kg Cohort D: 2.0 mg/kg Cohort E: 3.0 mg/kg Cohort F: 4.0 mg/kg Cohort G: 5.0 mg/kg
Doses of IMP will be administered intravenously on the morning of Day 1 following an overnight fast (minimum 8 hours).
During the Screening Period (within the 28 days prior to the subject receiving TP-271 or placebo) each subject will be assessed for eligibility. Each subject must sign and date an ICF prior to undergoing any study-related procedures.
All cohorts will follow the same study design (Figure 1). On Day -1, subjects will be admitted to the study unit so their eligibility can be confirmed. Subjects will be required to stay overnight at the study unit on Day -1. On Day 1, eligible subjects will be enrolled and randomized to receive either TP-271 or placebo. Subjects will be required to stay at the study unit from Day 1 through Day 5 to assess safety and obtain required PK samples. On Day 5, subjects will be discharged from the study unit. A final safety assessment will be performed once between Day 7 and Day 10 following the subject's dose of IMP.
- Conditions
- Pneumonia
- Being tested
- TP-271
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-271Drug
TP-271 is a novel, broad-spectrum tetracycline with potent activity against multidrug-resistant pathogens. It will be administered intravenously (IV) in doses ranging from 0.15 to 5.0 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Active comparator | IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 0.15 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion Receives: Drug: TP-271 |
| Cohort B | Active comparator | IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 0.45 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion Receives: Drug: TP-271 |
| Cohort C | Active comparator | IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 1.0 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion Receives: Drug: TP-271 |
| Cohort D | Active comparator | IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 2.0 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion Receives: Drug: TP-271 |
| Cohort E | Active comparator | IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 3.0 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion Receives: Drug: TP-271 |
| Cohort F | Active comparator | IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 4.0 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion Receives: Drug: TP-271 |
| Cohort G | Active comparator | IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 5.0 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion Receives: Drug: TP-271 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
The incidence, intensity, and type of adverse events (AE)
Outcome measures to be collected in support of the primary objective (safety and tolerability) include:
- The incidence, intensity, and type of AEs (from time of signing of informed consent form [ICF] through EOS);
- Changes in physical examination findings (Day -1 and EOS);
- Changes in vital signs (Day -1 through EOS);
- Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results (Days -1 through EOS); and
- Changes in ECG measurements (Days -1 through EOS).
Measured: Through study completion, appromiximately 39 days
Physical Exams
Changes in physical examination findings
Measured: Through study completion, appromiximately 39 days
Vital Signs
Changes in vital signs
Measured: Through study completion, appromiximately 39 days
Safety Laboratory
Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results
Measured: Through study completion, appromiximately 39 days
ECG measurements
Changes in ECG measurements
Measured: Through study completion, appromiximately 39 days
Secondary outcomes (15)
Plasma Pharmacokinetic (PK) Analysis
Plasma concentrations of TP-271 and its C-4 epimer TP-9555 for PK analysis
Measured: Days 1-5
Urine Pharmacokinetic (PK) Analysis
Urine concentrations of TP-271 and its C-4 epimer TP-9555
Measured: Days 1-5
PK parameters - Cmax
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for Cmax [The maximum observed plasma concentration]
Measured: Days 1-5
PK parameters - Tmax
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for Tmax [The time from dosing at which Cmax is apparent]
Measured: Days 1-5
PK parameters - C8
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for C8 [The concentration at 8 hours post-dose]
Measured: Days 1-5
PK parameters - C12
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for C12 [The concentration at 12 hours post-dose]
Measured: Days 1-5
PK parameters - C24
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for C24 [The concentration at 24 hours post-dose]
Measured: Days 1-5
PK parameters - AUC(0-last)
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for AUC(0-last) [The area under the concentration vs time curve from zero to the last measured time point]
Measured: Days 1-5
PK parameters - AUC(0-inf)
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for AUC(0-inf) [The area under the concentration vs time curve from time zero extrapolated to infinity]
Measured: Days 1-5
PK parameters - AUC%extrap
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for AUC%extrap [The percentage of AUC(0-inf) accounted for by extrapolation]
Measured: Days 1-5
PK parameters - Lambda-z
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for Lambda-z [Slope of the regression line passing through the apparent elimination phase in a concentration vs time plot]
Measured: Days 1-5
PK parameters - T1/2el
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for T1/2el [The elimination half-life]
Measured: Days 1-5
PK parameters - CL
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for CL [Clearance: the volume of plasma cleared per unit time]
Measured: Days 1-5
PK parameters - Vd
PK parameters will be calculated from the plasma concentration versus time data (as appropriate) for Vd [The volume of distribution]
Measured: Days 1-5
PK parameters - epimer/parent
The PK parameters of the epimer/parent will be calculated for Cmax and AUC(0-inf).
Measured: Days 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study start18 Dec 2015
- Primary completion28 Sep 2016
- Study completion12 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetraphase Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724085
- Sponsor's protocol ID
- TP-271-001
- Other IDs
- HHSN272201100028C
- Status last verified
- Dec 2021
- First submitted
- 4 Sep 2015
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous TP-271 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02724085
- Acronym / sponsor ID
- TP-271-001
- Conditions
- Pneumonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Tetraphase Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 18 Dec 2015 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 12 Dec 2016 (actual)
- First posted
- 31 Mar 2016 (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.
This is a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose, inpatient study to assess the safety, tolerability, and pharmacokinetics of TP-271 in healthy subjects. Subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study.
Detailed description
Up to seven cohorts of eight subjects each (up to a total of 56 subjects) will be enrolled. The eight subjects within each cohort will be randomized 6:2 to receive a single intravenous dose of TP-271 or placebo. The planned doses are:
Cohort A: 0.15 mg/kg Cohort B: 0.45 mg/kg Cohort C: 1.0 mg/kg Cohort D: 2.0 mg/kg Cohort E: 3.0 mg/kg Cohort F: 4.0 mg/kg Cohort G: 5.0 mg/kg
Doses of IMP will be administered intravenously on the morning of Day 1 following an overnight fast (minimum 8 hours).
During the Screening Period (within the 28 days prior to the subject receiving TP-271 or placebo) each subject will be assessed for eligibility. Each subject must sign and date an ICF prior to undergoing any study-related procedures.
All cohorts will follow the same study design (Figure 1). On Day -1, subjects will be admitted to the study unit so their eligibility can be confirmed. Subjects will be required to stay overnight at the study unit on Day -1. On Day 1, eligible subjects will be enrolled and randomized to receive either TP-271 or placebo. Subjects will be required to stay at the study unit from Day 1 through Day 5 to assess safety and obtain required PK samples. On Day 5, subjects will be discharged from the study unit. A final safety assessment will be performed once between Day 7 and Day 10 following the subject's dose of IMP.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Active comparator | Drug: TP-271IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 0.15 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion |
| Cohort B | Active comparator | Drug: TP-271IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 0.45 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion |
| Cohort C | Active comparator | Drug: TP-271IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 1.0 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion |
| Cohort D | Active comparator | Drug: TP-271IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 2.0 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion |
| Cohort E | Active comparator | Drug: TP-271IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 3.0 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion |
| Cohort F | Active comparator | Drug: TP-271IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 4.0 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion |
| Cohort G | Active comparator | Drug: TP-271IV dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 5.0 mg/kg single dose, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be within the age range of 18 to 50 years, inclusive, at the time of Screening.
- Voluntarily sign an IRB/Research Ethics Committee (IRB/REC)-approved ICF to participate in the study after all relevant aspects of the study have been explained and discussed with the subject and before undergoing any study related procedures.
- Have a body mass index (BMI) ≥18.0 and ≤33.0 kg/m2.
- Be clear of any history of, and have negative screen for, HIV 1 and 2 and hepatitis B and C.
- Have the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
Key exclusion criteria (27 listed)
- History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, and psychiatric/mental disease/disorders, which, in the opinion of the PI, may either put the subject at risk because of participation in the study, influence the results of the study, or influence the subject's ability to participate in the study.
- Clinical laboratory values that fall outside the eligibility range specified in the table in Appendix C are exclusionary. For the laboratory values that are not included in Appendix C, values outside of the reference range are exclusionary with the following exceptions:
- Low Chemistry Values High Chemistry Values Out of Range UA Out of Range Hematology Bicarbonate (> 18 mEq/L Chloride GGT HDL Cholesterol LDH LDL Cholesterol Phosphorus Triglycerides Chloride HDL Cholesterol LDL Cholesterol Phosphorus Triglycerides High or low specific gravity Cloudy Mucus Crystals Ketones (when blood glucose is normal) Hyaline casts High or low pH
- High hematocrit Basophils Monocytes MCV MCHC MCH RBC
- Blood pressure and pulse outside of the following ranges are exclusionary:
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 |
|---|---|---|
| TP-271TP-271 is a novel, broad-spectrum tetracycline with potent activity against multidrug-resistant pathogens. It will be administered intravenously (IV) in doses ranging from 0.15 to 5.0 mg/kg | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E, Cohort F, Cohort G |
Primary outcome
Adverse Events (AE)
Time frame: Through study completion, appromiximately 39 days
The incidence, intensity, and type of adverse events (AE) Outcome measures to be collected in support of the primary objective (safety and tolerability) include: * The incidence, intensity, and type of AEs (from time of signing of informed consent form [ICF] through EOS); * Changes in physical examination findings (Day -1 and EOS); * Changes in vital signs (Day -1 through EOS); * Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results (Days -1 through EOS); and * Changes in ECG measurements (Days -1 through EOS).
Physical Exams
Time frame: Through study completion, appromiximately 39 days
Changes in physical examination findings
Vital Signs
Time frame: Through study completion, appromiximately 39 days
Changes in vital signs
Safety Laboratory
Time frame: Through study completion, appromiximately 39 days
Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results
ECG measurements
Time frame: Through study completion, appromiximately 39 days
Changes in ECG measurements
15 secondary outcomes
Plasma Pharmacokinetic (PK) Analysis
Time frame: Days 1-5
Urine Pharmacokinetic (PK) Analysis
Time frame: Days 1-5
PK parameters - Cmax
Time frame: Days 1-5
PK parameters - Tmax
Time frame: Days 1-5
PK parameters - C8
Time frame: Days 1-5
PK parameters - C12
Time frame: Days 1-5
PK parameters - C24
Time frame: Days 1-5
PK parameters - AUC(0-last)
Time frame: Days 1-5
PK parameters - AUC(0-inf)
Time frame: Days 1-5
PK parameters - AUC%extrap
Time frame: Days 1-5
PK parameters - Lambda-z
Time frame: Days 1-5
PK parameters - T1/2el
Time frame: Days 1-5
PK parameters - CL
Time frame: Days 1-5
PK parameters - Vd
Time frame: Days 1-5
PK parameters - epimer/parent
Time frame: Days 1-5
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 13 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 TP-271 in people with Pneumonia, run by Tetraphase Pharmaceuticals, 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 7 inclusion and 27 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 13 Dec 2021. 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. 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?
Adverse Events (AE) (time frame: Through study completion, appromiximately 39 days). The study lists 5 primary outcomes in all. 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 13 Dec 2021; AzTrials last refreshed its copy on 26 Oct 2026.