Safety and Tolerability in Healthy VolunteersPhase 1NCT04783545
Phase I Study of VLX-1005 in Healthy Subjects
A Phase 1 study testing VLX-1005 in people with Safety and Tolerability in Healthy Volunteers, run by Veralox Therapeutics at 1 site in United States.
Trial summary
The principal objective of this study is to describe the safety of and tolerability to single and multiple doses of VLX-1005 in healthy subjects following intravenous (IV) administration. Other exploratory objectives are: To evaluate the pharmacokinetics and pharmacodynamics of VLX-1005 following IV administration. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability in Healthy Volunteers
- What is being tested?
- VLX-1005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2021to 11 Jan 2022
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female (non-lactating and not of childbearing potential) subjects age 19 to 55 inclusive.
- Females must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
- hysteroscopic sterilization
- bilateral tubal ligation or bilateral salpingectomy
- hysterectomy
- bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
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- Good general health, with no significant medical history. Subjects must have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study drug.
- Body weight ≥ 50 kg at the screening visit.
- Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
- Has laboratory values (clinical chemistry and hematology) within the normal reference range. Deviations from this range may be acceptable if they are considered 'not clinically significant' (NCS) by the PI.
- Males who have not been vasectomized participating in the study must agree to use at least 2 approved methods of contraception (ie double-barrier or barrier plus hormonal), or abstain from sexual intercourse, from Day -2 to 4 weeks after dosing (or last dose Parts B)
- Is a non-smoker and must not have used any nicotine products within three months prior to screening.
- Able and willing to attend the necessary visits to the study center.
Who cannot join
- Blood donation or recipient of blood transfusion in previous 12 weeks.
- History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. Cardiovascular history should include assessment of risk factors for Torsades de Pointes Risk (e.g., heart failure, pulmonary edema, cardiomyopathy, hypokalemia, hypomagnesemia, or hypocalcemia, or family history of Long QT Syndrome, syncope or sudden death).
- History of neoplastic disease (with the exception of adequately treated non-melanomatous skin carcinoma).
- Mentally or legally incapacitated (e.g., has significant emotional problems at the time of Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years).
- Fever (body temperature >38C) or symptomatic viral/bacterial infection or use of antibi-otics within 2 weeks prior to Screening.
- Supine resting blood pressure (BP) >140/90 mmHg or heart rate (HR) outside the range 40 to 100 beats per minute at Screening and at Day -1.
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- Clinically significant abnormality on ECG performed at the Screening Visit or prior to administration of the initial dose of study drug. (Sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or bundle branch block.
- Out of range (on repeat) testing for coagulation tests including fibrinogen.
- Clinically significant laboratory abnormalities including: Impaired renal function (estimated creatinine clearance (CrCl) of <80 mL/minute based on CrCl = (140-age [years])(body weight [kg])/(72)(serum creatinine [mg/dL])).
- Positive test for hepatitis C antibody, hepatitis B surface antigen, or human immunodefi-ciency virus (HIV) antibody at Screening.
- Participants with a positive toxicology screening panel (urine test including qualitative identi¬fication of barbiturates, tetrahydrocannabinol, amphetamines, benzodiazepines, opiates, cocaine, cotinine and ethanol).
- Participants with a history of substance abuse or dependency or history of recreational IV drug use (by self-declaration).
- Participant has a suspected history of alcohol abuse in the 6 months prior to screening.
- Use of NSAIDs, aspirin or aspirin-containing medications (and other medications affecting platelet function [for example cilostazol, clopidogrel, ticagrelor, prasugrel, dipyridamole]) in the 14 days prior to dosing with study medication.
- Unable to refrain from or anticipates the use of any medications, including prescription and non-prescription drugs and herbal remedies (such as St. John's Wort [Hypericum perforatum]), beginning 14 days (or 5 half-lives, whichever is longer) before administration of the initial dose of study drug and continuing throughout the study until the final study visit. There may be certain medications that are permitted at the discretion of the Investigator and Sponsor (including paracetamol/acetaminophen, medications for the treatment of AEs following administration of study drug).
- Subjects who are unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study.
- Have participated in any other investigational drug trial within 30 days of dosing in the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part, Double-blind, Placebo-controlled, Phase I Study of the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Intravenous VLX-1005 in Healthy Subjects
The principal objective of this study is to describe the safety of and tolerability to single and multiple doses of VLX-1005 in healthy subjects following intravenous (IV) administration.
Other exploratory objectives are:
To evaluate the pharmacokinetics and pharmacodynamics of VLX-1005 following IV administration.
- Being tested
- VLX-1005, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLX-1005Drug
VLX-1005 infusion
PlaceboDrug
Placebo infusion
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose Cohorts 1-6 | Experimental | Drug: VLX-1005 Receives: Drug: VLX-1005 |
| Single Ascending Dose Cohorts 1-6, Placebo | Placebo comparator | Drug: Placebo Receives: Drug: Placebo |
| Multiple Ascending Dose Cohorts 7-9 | Experimental | Drug: VLX-1005 Receives: Drug: VLX-1005 |
| Multiple Ascending Dose Cohorts 7-9, Placebo | Placebo comparator | Drug: Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting One or More Treatment-emergent Adverse Events
Measured: Baseline up to Day 29
Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Measured: Baseline up to Day 29
Number of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) or Telemetry Parameters at Least Once Post Dose
Measured: Baseline up to Day 29
Number of Participants Who Meet the Markedly Abnormal Criteria for Laboratory Values at Least Once Post Dose
Measured: Baseline up to Day 29
Secondary outcomes (4)
AUC(inf)
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for VLX-1005
Measured: day 1 pre-infusion and at multiple time points (up to 36 hours) post infusion
C(max)
Plasma Concentration at the end of Infusion for VLX-1005
Measured: day 1 at the end of infusion (1 hour after infusion starts)
T1/2
Terminal Disposition Phase Half-life for VLX-1005
Measured: day 1 pre-infusion and at multiple time points (up to 36 hours) post infusion
Pharmacodynamics of 12-Lipoxygenase Inhibition
12-HETE measurement in serum
Measured: day 1 pre-infusion and at multiple time points (up to 36 hours) post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start24 Mar 2021
- Primary completion11 Jan 2022
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Tolerability in Healthy VolunteersStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veralox Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allen Hunt, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783545
- Sponsor's protocol ID
- VLX-1005-001
- Status last verified
- Apr 2022
- First submitted
- 26 Feb 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Double-blind, Placebo-controlled, Phase I Study of the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Intravenous VLX-1005 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04783545
- Acronym / sponsor ID
- VLX-1005-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Veralox TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 5 Mar 2021 (actual)
- 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 principal objective of this study is to describe the safety of and tolerability to single and multiple doses of VLX-1005 in healthy subjects following intravenous (IV) administration.
Other exploratory objectives are:
To evaluate the pharmacokinetics and pharmacodynamics of VLX-1005 following IV administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose Cohorts 1-6 | Experimental | Drug: VLX-1005Drug: VLX-1005 |
| Single Ascending Dose Cohorts 1-6, Placebo | Placebo comparator | Drug: PlaceboDrug: Placebo |
| Multiple Ascending Dose Cohorts 7-9 | Experimental | Drug: VLX-1005Drug: VLX-1005 |
| Multiple Ascending Dose Cohorts 7-9, Placebo | Placebo comparator | Drug: PlaceboDrug: Placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy, adult, male or female (non-lactating and not of childbearing potential) subjects age 19 to 55 inclusive.
- Females must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
- Good general health, with no significant medical history. Subjects must have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study drug.
- Body weight ≥ 50 kg at the screening visit.
- Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
Key exclusion criteria (17 listed)
- Blood donation or recipient of blood transfusion in previous 12 weeks.
- History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. Cardiovascular history should include assessment of risk factors for Torsades de Pointes Risk (e.g., heart failure, pulmonary edema, cardiomyopathy, hypokalemia, hypomagnesemia, or hypocalcemia, or family history of Long QT Syndrome, syncope or sudden death).
- History of neoplastic disease (with the exception of adequately treated non-melanomatous skin carcinoma).
- Mentally or legally incapacitated (e.g., has significant emotional problems at the time of Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years).
- Fever (body temperature >38C) or symptomatic viral/bacterial infection or use of antibi-otics within 2 weeks prior to Screening.
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 |
|---|---|---|
| VLX-1005VLX-1005 infusion | Drug | Multiple Ascending Dose Cohorts 7-9, Single Ascending Dose Cohorts 1-6 |
| PlaceboPlacebo infusion | Drug | Multiple Ascending Dose Cohorts 7-9, Placebo, Single Ascending Dose Cohorts 1-6, Placebo |
Primary outcome
Number of Participants Reporting One or More Treatment-emergent Adverse Events
Time frame: Baseline up to Day 29
Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Time frame: Baseline up to Day 29
Number of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) or Telemetry Parameters at Least Once Post Dose
Time frame: Baseline up to Day 29
Number of Participants Who Meet the Markedly Abnormal Criteria for Laboratory Values at Least Once Post Dose
Time frame: Baseline up to Day 29
4 secondary outcomes
AUC(inf)
Time frame: day 1 pre-infusion and at multiple time points (up to 36 hours) post infusion
C(max)
Time frame: day 1 at the end of infusion (1 hour after infusion starts)
T1/2
Time frame: day 1 pre-infusion and at multiple time points (up to 36 hours) post infusion
Pharmacodynamics of 12-Lipoxygenase Inhibition
Time frame: day 1 pre-infusion and at multiple time points (up to 36 hours) post infusion
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 28 Apr 2022.
- 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.
Allen Hunt, MD principal investigator
Celerion
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 VLX-1005 in people with Safety and Tolerability in Healthy Volunteers, run by Veralox Therapeutics 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 13 inclusion and 17 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 28 Apr 2022. 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?
Number of Participants Reporting One or More Treatment-emergent Adverse Events (time frame: Baseline up to Day 29). The study lists 4 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 28 Apr 2022.