PharmacokineticsPhase 1NCT04219865
Safety, Tolerance and Pharmacokinetics Study of Compound Edaravone Injection
A Phase 1 study of Pharmacokinetics, run by Nanjing Yoko Biomedical Co., Ltd. at 1 site in China.
Trial summary
Study on the Safety, Tolerance and Pharmacokinetics of Single-dose, Increasing and Loading Dose and Maintenance Dose Sequential Intravenous Infusion of Compound Edaravone Injection in Chinese Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2019to 16 Aug 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-65 years old (including upper and lower limits);
- Weight ≥50 kg, body mass index (BMI) between 18-28 kg / m2 (including upper and lower limits);
- Understand and sign the informed consent voluntarily, and volunteer to participate in this research.
Who cannot join
- A history of diseases of the heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system judged by the investigator as clinically significant;
- A comprehensive physical examination, neurological examination, laboratory examination, ECG examination, or cognitive assessment indicates that the subject has an abnormality that the researcher has determined to be clinically significant;
- Have taken any drug within two weeks before the study administration, and the researcher believes that this situation may affect the evaluation results of this study;
- There is a history of food or drug allergy or allergies that the researcher judges to be clinically significant;
- Those with positive results of serological examination (HBsAg, anti-HCV, anti-HIV, TP-Ab);
- A history of alcohol or drug abuse that the investigator believes may affect the evaluation results of this study within one year before the study administration;
Show all 12Show fewer
- Cannot quit smoking or drinking during the study period or the carbon monoxide breath test> 7 ppm during the screening period CO breath test, so if the subject's CO breath is> 7ppm, but the urine cotinine test is negative, it means that the CO breath test result may be false positive, the subject can be enrolled;
- As a subject who has participated in any drug clinical trial within 3 months before the first administration of the study;
- Those who donated blood or blood products ≥400 mL or 2 units within three months of the study;
- Do not agree to avoid the use of tobacco, alcohol or caffeinated beverages, or vigorous exercise, or other factors that affect drug absorption, distribution, metabolism, excretion, etc. during the 24 hours before and during the test;
- Pregnant or lactating women, or those who tested positive for serum HCG before the test administration, or those who were unable or unwilling to take researcher-approved contraception during the study according to the researcher's instructions;
- Subjects with poor compliance or unable to comply with the relevant provisions of the research protocol due to personal reasons, the investigator judges that the subjects are not suitable to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: Study on the Safety, Tolerance and Pharmacokinetics of Single-dose, Increasing and Loading Dose and Maintenance Dose Sequential Intravenous Infusion of Compound Edaravone Injection in Chinese Healthy Volunteers
Study on the Safety, Tolerance and Pharmacokinetics of Single-dose, Increasing and Loading Dose and Maintenance Dose Sequential Intravenous Infusion of Compound Edaravone Injection in Chinese Healthy Volunteers
- Conditions
- Pharmacokinetics
- Being tested
- Group 1: Compound Edaravone/Placebo Injection, Group 2: Compound Edaravone/Placebo Injection, Group 3: Compound Edaravone/Placebo Injection, Group 4: Compound Edaravone/Placebo Injection, Group 5: Compound Edaravone/Placebo Injection
- Keywords
- Edaravone, Compound edaravone injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: Compound Edaravone/Placebo InjectionDrug
Compound Edaravone 30mg-600mg (containing edaravone 30 mg and 2-aminoethanesulfonic acid 600 mg) / placebo single intravenous infusion for 30min
Group 2: Compound Edaravone/Placebo InjectionDrug
Compound Edaravone 60mg-1200mg (containing edaravone 60 mg and 2-aminoethanesulfonic acid 1200 mg) / placebo single intravenous infusion for 30min
Group 3: Compound Edaravone/Placebo InjectionDrug
Compound Edaravone 90mg-1800mg (containing edaravone 90 mg and 2-aminoethanesulfonic acid 1800 mg) / placebo single intravenous infusion for 30min
Group 4: Compound Edaravone/Placebo InjectionDrug
Compound Edaravone 120mg-2400mg (containing edaravone 120 mg and 2-aminoethanesulfonic acid 2400 mg) / placebo single intravenous infusion for 30min
Group 5: Compound Edaravone/Placebo InjectionDrug
Maximum tolerated dose of drug / placebo for a single intravenous infusion for 30 minutes three times a day at an interval of 8 h until the last dose on the morning of Day 3, after which the sequential test drug 30 mg-600 mg / placebo will be administered daily from Day 3 night Intravenous infusion, 30 minutes at 12-hour intervals until morning on Day 7
| Study group | Role | What they receive |
|---|---|---|
| Compound Edaravone | Active comparator | 10 mL per vial (containing edaravone 10 mg and 2-aminoethanesulfonic acid 200 mg) Receives: Drug: Group 1: Compound Edaravone/Placebo Injection; Drug: Group 2: Compound Edaravone/Placebo Injection; Drug: Group 3: Compound Edaravone/Placebo Injection; Drug: Group 4: Compound Edaravone/Placebo Injection; Drug: Group 5: Compound Edaravone/Placebo Injection |
| Placebo | Placebo comparator | 10 mL per vial Receives: Drug: Group 1: Compound Edaravone/Placebo Injection; Drug: Group 2: Compound Edaravone/Placebo Injection; Drug: Group 3: Compound Edaravone/Placebo Injection; Drug: Group 4: Compound Edaravone/Placebo Injection; Drug: Group 5: Compound Edaravone/Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) of edaravone and 2-aminoethanesulfonic Acid in single dose groups of compound edaravone injection
Measured: 24 hours
Area under curve (AUC) of edaravone and 2-aminoethanesulfonic Acid in multiple doses group after multiple intravenous infusion of compound edaravone injection
Measured: 7 Days
Cmax of edaravone and 2-aminoethanesulfonic Acid in single dose groups of compound edaravone injection
Measured: 24 hours
Cmax of edaravone and 2-aminoethanesulfonic Acid in multiple doses group after multiple intravenous infusion of compound edaravone injection
Measured: 7 Days
Secondary outcomes (1)
Incidence of adverse events of compound edaravone injection
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start5 Jun 2019
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Factorial
- Model description
- Factorial Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219865
- Sponsor's protocol ID
- NJYK-CPEDRV-I
- Status last verified
- Mar 2021
- First submitted
- 18 Dec 2019
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety, Tolerance and Pharmacokinetics of Single-dose, Increasing and Loading Dose and Maintenance Dose Sequential Intravenous Infusion of Compound Edaravone Injection in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04219865
- Acronym / sponsor ID
- NJYK-CPEDRV-I
- Conditions
- Pharmacokinetics
- Keywords
- Edaravone, Compound edaravone injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 7 Jan 2020 (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.
Study on the Safety, Tolerance and Pharmacokinetics of Single-dose, Increasing and Loading Dose and Maintenance Dose Sequential Intravenous Infusion of Compound Edaravone Injection in Chinese Healthy Volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Factorial Assignment
| Arm | Type | Receives |
|---|---|---|
| Compound Edaravone | Active comparator | Drug: Group 1: Compound Edaravone/Placebo Injection, Drug: Group 2: Compound Edaravone/Placebo Injection, Drug: Group 3: Compound Edaravone/Placebo Injection, Drug: Group 4: Compound Edaravone/Placebo Injection, Drug: Group 5: Compound Edaravone/Placebo Injection10 mL per vial (containing edaravone 10 mg and 2-aminoethanesulfonic acid 200 mg) |
| Placebo | Placebo comparator | Drug: Group 1: Compound Edaravone/Placebo Injection, Drug: Group 2: Compound Edaravone/Placebo Injection, Drug: Group 3: Compound Edaravone/Placebo Injection, Drug: Group 4: Compound Edaravone/Placebo Injection, Drug: Group 5: Compound Edaravone/Placebo Injection10 mL per vial |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18-65 years old (including upper and lower limits);
- Weight ≥50 kg, body mass index (BMI) between 18-28 kg / m2 (including upper and lower limits);
- Understand and sign the informed consent voluntarily, and volunteer to participate in this research.
Key exclusion criteria (12 listed)
- A history of diseases of the heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system judged by the investigator as clinically significant;
- A comprehensive physical examination, neurological examination, laboratory examination, ECG examination, or cognitive assessment indicates that the subject has an abnormality that the researcher has determined to be clinically significant;
- Have taken any drug within two weeks before the study administration, and the researcher believes that this situation may affect the evaluation results of this study;
- There is a history of food or drug allergy or allergies that the researcher judges to be clinically significant;
- Those with positive results of serological examination (HBsAg, anti-HCV, anti-HIV, TP-Ab);
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 |
|---|---|---|
| Group 1: Compound Edaravone/Placebo InjectionCompound Edaravone 30mg-600mg (containing edaravone 30 mg and 2-aminoethanesulfonic acid 600 mg) / placebo single intravenous infusion for 30min | Drug | Compound Edaravone, Placebo |
| Group 2: Compound Edaravone/Placebo InjectionCompound Edaravone 60mg-1200mg (containing edaravone 60 mg and 2-aminoethanesulfonic acid 1200 mg) / placebo single intravenous infusion for 30min | Drug | Compound Edaravone, Placebo |
| Group 3: Compound Edaravone/Placebo InjectionCompound Edaravone 90mg-1800mg (containing edaravone 90 mg and 2-aminoethanesulfonic acid 1800 mg) / placebo single intravenous infusion for 30min | Drug | Compound Edaravone, Placebo |
| Group 4: Compound Edaravone/Placebo InjectionCompound Edaravone 120mg-2400mg (containing edaravone 120 mg and 2-aminoethanesulfonic acid 2400 mg) / placebo single intravenous infusion for 30min | Drug | Compound Edaravone, Placebo |
| Group 5: Compound Edaravone/Placebo InjectionMaximum tolerated dose of drug / placebo for a single intravenous infusion for 30 minutes three times a day at an interval of 8 h until the last dose on the morning of Day 3, after which the sequential test drug 30 mg-600 mg / placebo will be administered daily from Day 3 night Intravenous infusion, 30 minutes at 12-hour intervals until morning on Day 7 | Drug | Compound Edaravone, Placebo |
Primary outcome
Area under curve (AUC) of edaravone and 2-aminoethanesulfonic Acid in single dose groups of compound edaravone injection
Time frame: 24 hours
Area under curve (AUC) of edaravone and 2-aminoethanesulfonic Acid in multiple doses group after multiple intravenous infusion of compound edaravone injection
Time frame: 7 Days
Cmax of edaravone and 2-aminoethanesulfonic Acid in single dose groups of compound edaravone injection
Time frame: 24 hours
Cmax of edaravone and 2-aminoethanesulfonic Acid in multiple doses group after multiple intravenous infusion of compound edaravone injection
Time frame: 7 Days
1 secondary outcome
Incidence of adverse events of compound edaravone injection
Time frame: 7 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 22 Mar 2021.
Related trials for Pharmacokinetics
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
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 of Pharmacokinetics, run by Nanjing Yoko Biomedical Co., Ltd. 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 3 inclusion and 12 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 22 Mar 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 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?
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?
Area under curve (AUC) of edaravone and 2-aminoethanesulfonic Acid in single dose groups of compound edaravone injection (time frame: 24 hours). 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 22 Mar 2021.