Hand, Foot and Mouth DiseasePhase 1NCT03804749
Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium
A Phase 1 study testing suramin sodium in people with Hand, Foot and Mouth Disease, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, single-dose with three incremental doses, Phase 1 study to evaluate the tolerance and pharmacokinetics of suramin sodium for injection in Chinese healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot and Mouth Disease
- What is being tested?
- suramin sodium
- 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 siteChina
- Study dates
- 19 Dec 2018to 19 Dec 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers who fully understand the purpose, content, benefits and possible adverse reactions of the test and voluntarily sign written informed consent prior to the commencement of any test-related activities.
- Healthy males or females, aged 18 to 45 years (including 18 and 45 years).
- Male subjects weighed 50-75 kg (including 50 and 75 kg), female subjects weighed 45-75 kg (including 45 and 75 kg), body mass index (BMI) was 18.0-26.0 kg/m2 (including 18.0 and 26.0 kg/m2), where BMI = body weight (kg)/height2 (m2).
- Have the ability to communicate with investigator and abide by the management regulations of the hospital and the clinical research.
Who cannot join
- Fail in physical examination, vital signs measurement, standard 12-lead electrocardiogram, chest X-ray, laboratory examination [blood routine, urine routine, blood biochemistry, blood coagulation function, infectious diseases, blood pregnancy (only for women of childbearing age), as judged by the investigator to be of clinical significance.
- With gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immunity, mental or cardiovascular diseases.
- Has allergic constitution (allergic to two or more substances), or allergic history, or known allergic to suramin sodium.
- Cannot tolerate venipuncture and/or have a history of fainting blood or needle.
- Has massive blood loss (> 400 mL) or had donated blood/blood components within the first six months of screening, or who planned to donate blood/blood components during the study period.
- Had participated in clinical trials of drugs and took research drugs within three months before screening.
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- Smoke more than five cigarettes a day (including nicotine substitutes) or the same amount of tobacco products in the first three months of screening.
- Has history of drug abuse within 5 years before screening, or those who had used drugs within 3 months before screening.
- Has a history of alcoholism or moderate alcoholism in the first two years of screening (moderate alcoholism is defined as drinking more than 3 units per day or 21 units per week; a bottle of 350 mL beer, 120 mL white wine, 150 mL wine or 30 mL spirits is one unit).
- Pregnant or lactating women, or subjects (or their partners) who have pregnancy plans during the trial and within three months after the end of the study, or who do not agree to use non-drug contraceptive measures during the trial.
- Positive urine drug screening in screening stage.
- Alcohol urine positive in screening stage.
- Nicotine positive in screening stage.
- With acute diseases in screening period.
- Had used any prescription, over-the-counter, vitamin products or Chinese herbal medicines within 14 days before enrollment.
- Female subjects of childbearing age who did not take non-drug contraceptive measures within 14 days before admission.
- Not suitable for participating into the trial as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Jianzhong Shentu, Ph.D.（Pharm）, 0571 87236560, stjz@zju.edu.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium in Healthy Chinese Adults
This is a randomized, double-blind, placebo-controlled, single-dose with three incremental doses, Phase 1 study to evaluate the tolerance and pharmacokinetics of suramin sodium for injection in Chinese healthy adults.
Read the detailed description
A total of 36 subjects are divided into three dosage groups: 10mg/kg, 15mg/kg and 20mg/kg, in which 20mg/kg is the conventional dosage per international pharmacopoeias for established indications of suramin sodium. Each dose group contains 12 subjects. By randomization, 10 of them receive suramin sodium while 2 of them receive placebo (0.9% sodium chloride injection）. The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg) and high dose (20mg/kg) groups, only after the safety in the previous dose group has been demonstrated.
All subjects in each dose group will be un-blinded after blood/urine collection and safety evaluation on Day 28. After that, blood and urine samples on suramin-dosing subjects will continue to collect on Days 56、84、112 and 140.
Subjects receiving placebo will complete the study on Day 28 if no AE is observed, or follow up till the adverse event (AE) return to normal or stabilize if AE is detected.
Blood and urine samples will be tested by a validated LC/MS method for pharmacokinetic study.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- suramin sodium, placebo
- Keywords
- suramin sodium
- Medical subject headings
- Hand, Foot and Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suramin sodiumDrug
The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg) and high dose (20mg/kg) groups, only after the safety in the previous dose group has been demonstrated.。
placeboOther
Also called 0.9% sodium chloride injection
Placebo is 0.9% sodium chloride injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1-1 | Experimental | The dose of suramin sodium is 10 mg/kg Receives: Drug: suramin sodium |
| Group 1-2 | Placebo comparator | The placebo is 0.9% sodium chloride injection Receives: Other: placebo |
| Group 2-1 | Experimental | The dose of suramin sodium is 15mg/kg Receives: Drug: suramin sodium |
| Group 2-2 | Placebo comparator | The placebo is 0.9% sodium chloride injection Receives: Other: placebo |
| Group 3-1 | Experimental | The dose of suramin sodium is 20mg/kg Receives: Drug: suramin sodium |
| Group 3-2 | Placebo comparator | The placebo is 0.9% sodium chloride injection Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Adverse events
Measured: [ Day 1 to Day 140 ]
the area under the plasma concentration-time curve (AUC) from time zero to the time of the last measurable concentration (AUC0-t) of suramin sodium
Pharmacokinetics parameters
Measured: [ Day 1 to Day 140 after study drug administration ]
the AUC from time zero to infinity (AUC0-inf) of suramin sodium
Pharmacokinetics parameters
Measured: [ Day 1 to Day 140 after study drug administration ]
maximum plasma concentration (Cmax ) of suramin sodium
Pharmacokinetics parameters
Measured: [ Day 1 to Day 140 after study drug administration ]
half life （t1/2） of suramin sodium
Pharmacokinetics parameters
Measured: [Day 1 to Day 140 after study drug administration ]
clearance （CL） of suramin sodium
Pharmacokinetics parameters
Measured: [ Day 1 to Day 140 after study drug administration ]
apparent volume of distribution（Vd） of suramin sodium
Pharmacokinetics parameters
Measured: [ Day 1 to Day 140 after study drug administration ]
the amount of drug excreted into the urine from time zero to time 7 days（Ae0-t） of suramin sodium
Pharmacokinetics parameters
Measured: [ Day 1 to Day 7 after study drug administration ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start19 Dec 2018
- Primary completion19 Dec 2019 (estimated)
- Study completion19 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot and Mouth DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Kangda Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, shentu jianzhong, First Affiliated Hospital of Zhejiang University
- Investigators
- First Affiliated Hospital Zhejiang University, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804749
- Sponsor's protocol ID
- LC00-043
- Status last verified
- Jan 2019
- First submitted
- 28 Dec 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium in Healthy Chinese Adults
- ClinicalTrials.gov ID
- NCT03804749
- Acronym / sponsor ID
- LC00-043
- Conditions
- Hand, Foot and Mouth Disease
- Keywords
- suramin sodium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Guangdong Kangda Pharmaceutical Co., Ltd
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 19 Dec 2019 (estimated)
- Study completion
- 19 Dec 2020 (estimated)
- First posted
- 15 Jan 2019 (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.
This is a randomized, double-blind, placebo-controlled, single-dose with three incremental doses, Phase 1 study to evaluate the tolerance and pharmacokinetics of suramin sodium for injection in Chinese healthy adults.
Detailed description
A total of 36 subjects are divided into three dosage groups: 10mg/kg, 15mg/kg and 20mg/kg, in which 20mg/kg is the conventional dosage per international pharmacopoeias for established indications of suramin sodium. Each dose group contains 12 subjects. By randomization, 10 of them receive suramin sodium while 2 of them receive placebo (0.9% sodium chloride injection）. The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg) and high dose (20mg/kg) groups, only after the safety in the previous dose group has been demonstrated.
All subjects in each dose group will be un-blinded after blood/urine collection and safety evaluation on Day 28. After that, blood and urine samples on suramin-dosing subjects will continue to collect on Days 56、84、112 and 140.
Subjects receiving placebo will complete the study on Day 28 if no AE is observed, or follow up till the adverse event (AE) return to normal or stabilize if AE is detected.
Blood and urine samples will be tested by a validated LC/MS method for pharmacokinetic study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1-1 | Experimental | Drug: suramin sodiumThe dose of suramin sodium is 10 mg/kg |
| Group 1-2 | Placebo comparator | Other: placeboThe placebo is 0.9% sodium chloride injection |
| Group 2-1 | Experimental | Drug: suramin sodiumThe dose of suramin sodium is 15mg/kg |
| Group 2-2 | Placebo comparator | Other: placeboThe placebo is 0.9% sodium chloride injection |
| Group 3-1 | Experimental | Drug: suramin sodiumThe dose of suramin sodium is 20mg/kg |
| Group 3-2 | Placebo comparator | Other: placeboThe placebo is 0.9% sodium chloride injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers who fully understand the purpose, content, benefits and possible adverse reactions of the test and voluntarily sign written informed consent prior to the commencement of any test-related activities.
- Healthy males or females, aged 18 to 45 years (including 18 and 45 years).
- Male subjects weighed 50-75 kg (including 50 and 75 kg), female subjects weighed 45-75 kg (including 45 and 75 kg), body mass index (BMI) was 18.0-26.0 kg/m2 (including 18.0 and 26.0 kg/m2), where BMI = body weight (kg)/height2 (m2).
- Have the ability to communicate with investigator and abide by the management regulations of the hospital and the clinical research.
Key exclusion criteria (17 listed)
- Fail in physical examination, vital signs measurement, standard 12-lead electrocardiogram, chest X-ray, laboratory examination [blood routine, urine routine, blood biochemistry, blood coagulation function, infectious diseases, blood pregnancy (only for women of childbearing age), as judged by the investigator to be of clinical significance.
- With gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immunity, mental or cardiovascular diseases.
- Has allergic constitution (allergic to two or more substances), or allergic history, or known allergic to suramin sodium.
- Cannot tolerate venipuncture and/or have a history of fainting blood or needle.
- Has massive blood loss (> 400 mL) or had donated blood/blood components within the first six months of screening, or who planned to donate blood/blood components during the study period.
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 |
|---|---|---|
| suramin sodiumThe trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg) and high dose (20mg/kg) groups, only after the safety in the previous dose group has been demonstrated.。 | Drug | Group 1-1, Group 2-1, Group 3-1 |
| placeboAlso: 0.9% sodium chloride injectionPlacebo is 0.9% sodium chloride injection. | Other | Group 1-2, Group 2-2, Group 3-2 |
Primary outcome
Number of subjects with adverse events
Time frame: [ Day 1 to Day 140 ]
Adverse events
the area under the plasma concentration-time curve (AUC) from time zero to the time of the last measurable concentration (AUC0-t) of suramin sodium
Time frame: [ Day 1 to Day 140 after study drug administration ]
Pharmacokinetics parameters
the AUC from time zero to infinity (AUC0-inf) of suramin sodium
Time frame: [ Day 1 to Day 140 after study drug administration ]
Pharmacokinetics parameters
maximum plasma concentration (Cmax ) of suramin sodium
Time frame: [ Day 1 to Day 140 after study drug administration ]
Pharmacokinetics parameters
half life （t1/2） of suramin sodium
Time frame: [Day 1 to Day 140 after study drug administration ]
Pharmacokinetics parameters
clearance （CL） of suramin sodium
Time frame: [ Day 1 to Day 140 after study drug administration ]
Pharmacokinetics parameters
apparent volume of distribution（Vd） of suramin sodium
Time frame: [ Day 1 to Day 140 after study drug administration ]
Pharmacokinetics parameters
the amount of drug excreted into the urine from time zero to time 7 days（Ae0-t） of suramin sodium
Time frame: [ Day 1 to Day 7 after study drug administration ]
Pharmacokinetics parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: No
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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.
First Affiliated Hospital Zhejiang University principal investigator
First Affiliated Hospital of Zhejiang University
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 suramin sodium in people with Hand, Foot and Mouth Disease, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Jan 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianzhong Shentu, Ph.D.（Pharm） (0571 87236560, stjz@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (time frame: [ Day 1 to Day 140 ]). The study lists 8 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 15 Jan 2019.