HealthyPhase 1NCT02333318
A Single Ascending Dose Escalation to Investigate Safety and PK of VVZ-149 Injection in Healthy Older Male Volunteers
A Phase 1 study testing VVZ-149 injection in people with Healthy, run by Vivozon, Inc..
Trial summary
The objective of this study is to investigate the safety, tolerability and pharmacokinetics (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older male volunteers. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- VVZ-149 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Oct 2014
- 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 50 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily agree to participate and sign an IRB-approved informed consent form (ICF) prior to receiving any of the screening procedures
- Healthy male subjects aged between 50-84, inclusive at screening (the subjects aged 65 years or over can participate only in the single dose trial)
- Subjects with body weights between 50-90 kg, inclusive and with body mass index (BMI) between 18.0-29.9 kg/m2, inclusive
- Healthy subjects satisfying eligibility at screening (medical histories, physical examination, vital sign, electrocardiogram (ECG), hematology, clinical chemistry and urinalysis)
- Subjects who willing to use an medicinal allowed method of contraception or sterility during the study period
Who cannot join
- Subjects who have a presence or history of clinically significant hepatic, renal, neurologic, immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric (e.g. mood disorders or obsessive-compulsive disorder) diseases (subjects with currently well-controlled conditions including hypertension, hyperlipidemia, arthritis, prostatic hypertrophy and cataracts may allow to participate at the discretion of the investigator.)
- Subjects with chronic infection or meaningful acute infection
- Subjects who have a history of clinically significant hypersensitivities or hypersensitivities to the ingredient of same family with IP and other drug (e.g. aspirin and antibiotics)
- Subjects who have a family history of chronic pain or with a first-degree relative with chronic pain
- Subjects who have a clinically significant ECG abnormalities or QTc interval >450 ms
- Subjects who meet the following criteria at screening:
Show all 20Show fewer
- AST or ALT level > 3 times the upper limit of the normal range
- Calculated eGFR by MDRD equation < 60 ml/min
- Platelets ≤ 75,000/mm3, Hemoglobin ≤ 9 g/dL, Neutrophils absolute ≤ 1000/mm3
- Subjects who show the following vital signs at the screening:
- Systolic Blood Pressure (SBP): <92 mmHg or >160 mmHg
- Diastolic Blood Pressure (DBP): <50 mmHg or >95 mmHg
- Subjects who have a history of drug abuse or a positive urine screening for drug abuse
- Subjects who have taken any prescribed or herbal medicine within one week before the first administration of the IP or any non-prescribed medicine or vitamin supplement within three days before the first administration of the IP (if all other conditions are satisfied, these subjects may be eligible for the trial as judged by the investigator)
- Subjects who have participated in any other clinical trial within two months before the first administration of the IP
- Subjects who have donated a unit of whole blood within two months or blood components within one month before the first administration of the IP, or who have received blood transfusion within one month before the first administration of the IP
- Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking throughout the trial
- Smokers who consume more than average of 10 cigarettes per day over the past three months or who are unable to abstain from smoking throughout the trial
- Subjects who consume or are unable to abstain from products containing caffeine (e.g. coffee, green tea, black tea and sodas) within 24 hours before the first administration of the IP and until discharge from the hospital
- Subjects judged ineligible for the study by the investigator for reasons of medical, psychological, social and geographical conditions causing poor study compliance
About this study
Official title: A Single Ascending Dose Escalation Clinical Trial to Investigate Safety and Pharmacokinetics of VVZ-149 Injection in Healthy Older Male Volunteers
The objective of this study is to investigate the safety, tolerability and pharmacokinetics (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older male volunteers.
Read the detailed description
VVZ-149 injection, an investigational product (IP) in this clinical study, is a multi-target analgesic drug candidate against glycine transporter type II (GlyT2) and serotonin receptor 2A (5HT2A). The target receptors have been known to play important roles in the induction and transmission of pain signals in the pain-related neural system. There have been efforts to develop new drugs that selectively antagonize the GlyT2 or 5HT2A, but it was unsuccessful due to limitations of single-target drugs. VVZ-149 showed morphine-comparable analgesic and gabapentin-comparable anti-allodynic effects in various rat models of pain.
- Conditions
- Healthy
- Being tested
- VVZ-149 injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VVZ-149 injectionDrug
Also called VVZ-149 injection or water for injection
Colorless, transparent liquid in water for injection
PlaceboOther
Also called VVZ-149 injection or water for injection
water for injection
| Study group | Role | What they receive |
|---|---|---|
| Single Dose_VVZ-149 injection | Experimental | 1. Cohort A (50-64 years old), Cohort B (65-84 years old)
2. For 2.5, 5mg/kg
3. 4-hr intravenous infusion of VVZ-149 injection
4. 6 subjects will be administered within each age group. Total 24 subjects will participate. Receives: Drug: VVZ-149 injection |
| Loading/Maintenance_VVZ-149 injection | Experimental | 1. Cohort A (50-64 years old) This trial is conducted only in the Cohort A one week after the single IV infusion.
2. For Loading + Maintenance dose: 0.75 mg/kg+ 0.55 mg/kg/h, 1.5 mg/kg + 1.10 mg/kg/h
3. intravenous infusion
4. 4 subjects will be randomly assigned within each dose group, respectively. Total 8 subjects will participate. Receives: Drug: VVZ-149 injection |
| Loading/Maintenance_Placebo | Placebo comparator | 1. Cohort A (50-64 years old)
2. For Loading + Maintenance dose: 0.75 mg/kg+ 0.55 mg/kg/h, 1.5 mg/kg + 1.10 mg/kg/h
3. intravenous infusion
4. 2 subjects will be randomly assigned within each dose group, respectively. Total 4 subjects will participate. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity and maximum tolerated dose
Any Common Toxicity Criteria for Adverse Effects grade 3 or more adverse event , All significant toxicity judged by the investigator
Measured: 8 day
Secondary outcomes (1)
Safety and Tolerability as measured by Adverse event, physical examination, vital signs, 12-lead ECG, consecutive ECG, SpO2 monitoring and Clinical laboratory.
Adverse event, physical examination, vital signs, 12-lead ECG, consecutive ECG, SpO2 monitoring, Clinical laboratory
Measured: 8 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivozon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Yong Chung, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333318
- Sponsor's protocol ID
- PT-VVZ149-02
- Status last verified
- Jan 2015
- First submitted
- 24 Dec 2014
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose Escalation Clinical Trial to Investigate Safety and Pharmacokinetics of VVZ-149 Injection in Healthy Older Male Volunteers
- ClinicalTrials.gov ID
- NCT02333318
- Acronym / sponsor ID
- PT-VVZ149-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vivozon, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 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 objective of this study is to investigate the safety, tolerability and pharmacokinetics (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older male volunteers.
Detailed description
VVZ-149 injection, an investigational product (IP) in this clinical study, is a multi-target analgesic drug candidate against glycine transporter type II (GlyT2) and serotonin receptor 2A (5HT2A). The target receptors have been known to play important roles in the induction and transmission of pain signals in the pain-related neural system. There have been efforts to develop new drugs that selectively antagonize the GlyT2 or 5HT2A, but it was unsuccessful due to limitations of single-target drugs. VVZ-149 showed morphine-comparable analgesic and gabapentin-comparable anti-allodynic effects in various rat models of pain.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Dose_VVZ-149 injection | Experimental | Drug: VVZ-149 injection1. Cohort A (50-64 years old), Cohort B (65-84 years old) 2. For 2.5, 5mg/kg 3. 4-hr intravenous infusion of VVZ-149 injection 4. 6 subjects will be administered within each age group. Total 24 subjects will participate. |
| Loading/Maintenance_VVZ-149 injection | Experimental | Drug: VVZ-149 injection1. Cohort A (50-64 years old) This trial is conducted only in the Cohort A one week after the single IV infusion. 2. For Loading + Maintenance dose: 0.75 mg/kg+ 0.55 mg/kg/h, 1.5 mg/kg + 1.10 mg/kg/h 3. intravenous infusion 4. 4 subjects will be randomly assigned within each dose group, respectively. Total 8 subjects will participate. |
| Loading/Maintenance_Placebo | Placebo comparator | Other: Placebo1. Cohort A (50-64 years old) 2. For Loading + Maintenance dose: 0.75 mg/kg+ 0.55 mg/kg/h, 1.5 mg/kg + 1.10 mg/kg/h 3. intravenous infusion 4. 2 subjects will be randomly assigned within each dose group, respectively. Total 4 subjects will participate. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who voluntarily agree to participate and sign an IRB-approved informed consent form (ICF) prior to receiving any of the screening procedures
- Healthy male subjects aged between 50-84, inclusive at screening (the subjects aged 65 years or over can participate only in the single dose trial)
- Subjects with body weights between 50-90 kg, inclusive and with body mass index (BMI) between 18.0-29.9 kg/m2, inclusive
- Healthy subjects satisfying eligibility at screening (medical histories, physical examination, vital sign, electrocardiogram (ECG), hematology, clinical chemistry and urinalysis)
- Subjects who willing to use an medicinal allowed method of contraception or sterility during the study period
Key exclusion criteria (20 listed)
- Subjects who have a presence or history of clinically significant hepatic, renal, neurologic, immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric (e.g. mood disorders or obsessive-compulsive disorder) diseases (subjects with currently well-controlled conditions including hypertension, hyperlipidemia, arthritis, prostatic hypertrophy and cataracts may allow to participate at the discretion of the investigator.)
- Subjects with chronic infection or meaningful acute infection
- Subjects who have a history of clinically significant hypersensitivities or hypersensitivities to the ingredient of same family with IP and other drug (e.g. aspirin and antibiotics)
- Subjects who have a family history of chronic pain or with a first-degree relative with chronic pain
- Subjects who have a clinically significant ECG abnormalities or QTc interval >450 ms
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 |
|---|---|---|
| VVZ-149 injectionAlso: VVZ-149 injection or water for injectionColorless, transparent liquid in water for injection | Drug | Loading/Maintenance_VVZ-149 injection, Single Dose_VVZ-149 injection |
| PlaceboAlso: VVZ-149 injection or water for injectionwater for injection | Other | Loading/Maintenance_Placebo |
Primary outcome
Dose-limiting toxicity and maximum tolerated dose
Time frame: 8 day
Any Common Toxicity Criteria for Adverse Effects grade 3 or more adverse event , All significant toxicity judged by the investigator
1 secondary outcome
Safety and Tolerability as measured by Adverse event, physical examination, vital signs, 12-lead ECG, consecutive ECG, SpO2 monitoring and Clinical laboratory.
Time frame: 8 day
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 Mar 2019.
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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.
Jae Yong Chung, MD, PhD principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VVZ-149 injection in people with Healthy, run by Vivozon, Inc..
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 20 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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Dose-limiting toxicity and maximum tolerated dose (time frame: 8 day). 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 Mar 2019.