Healthy Adult SubjectsPhase 1NCT06107205
Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects
A Phase 1 study testing TTYP01, Radicava and Radicava ORS in people with Healthy Adult Subjects, run by Shanghai Auzone Biological Technology Co., Ltd. at 1 site in United States.
Trial summary
This is a Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions.The objective is To characterize the bioequivalence、safety and tolerability of… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- TTYP01, Radicava and Radicava ORS
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 14 Dec 2023
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all inclusion criteria at screening (or as noted) to be eligible for study participation, as follows:
- Informed consent signed and dated by the subject
- Healthy male and female subjects of any ethnic and racial origin, aged 20 to 45 years, inclusive
- Female subjects who:
- Are postmenopausal (defined as a minimum of 12 consecutive months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone level > 40 IU/L), or
- Are surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation), confirmed by medical documentations, or
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- Are of child-bearing potential must agree to use at least 1 highly effective method of contraception from at least 1 month prior to the initiation of the study through 3 months after the final dose, where highly effective methods of contraception include:
- Intrauterine device
- Intrauterine system
- Contraceptive implant
- Combined injectable contraceptives
- Hormonal oral contraceptives when used in combination with male condoms with spermicide
- If a female subject confirms that her male partner(s) has been verified to be clinically sterile (ie, documented infertility or surgical sterilization), this method is acceptable as the only means of contraception
- Note: The following are not acceptable methods of contraception:
- Periodic sexual abstinence (eg, calendar, ovulation, symptothermal, and post-ovulation methods), declaration of sexual abstinence for the duration of the study, withdrawal, and lactational amenorrhea method
- Spermicides alone
- Hormonal oral contraceptives alone
- Male condoms used in combination with female condoms or
- Agrees to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.
- Male subjects who are sexually active and whose partners are females of child-bearing potential, even if surgically sterilized (ie, status post vasectomy), who:
- Avoid sperm donation during the entire study period and through 90 days after the last dose of study drugs, and
- Agree to practice effective barrier contraception, or
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject
- Body mass index (BMI) of 19 to 30 kg/m2 (inclusive) (BMI = weight (kg)/(height [m])2)
- Non-smokers (defined as having abstained from tobacco- or nicotine-containing products [eg, cigarettes, chewing tobacco, snuff, nicotine patches, and electronic cigarettes] in the 6 months prior to screening), stable light smokers, and ex-smokers will be included. Stable light and ex-smokers are defined as follows: "A light smoker is defined as someone smoking ≤5 cigarettes per day; an ex-smoker is someone who has completely stopped smoking for at least 3 months."
- In good health, as determined by the investigator at screening and confirmed at check-in, with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
- Subjects must be willing to understand and able to comply with all research procedures and restrictions, and are able to communicate effectively with researchers.
Who cannot join
- Subjects will not be eligible for study participation if they meet any of the exclusion criteria at screening (or as noted), or will be discontinued at the discretion of the investigator in consultation with the medical monitor if they develop any of the exclusion criteria during the study.
- History of any hypersensitivity or allergic reaction to active ingredients or excipients of the study drugs (eg, known allergy to bisulfite containing foods such as bottled lemon juice, grape juice, canned fruits, wine, jam, jelly, etc.)
- Positive test result for infectious diseases at screening or baseline, including human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C virus antibody, and syphilis antibody
- Positive alcohol test at screening or baseline, or has a history of alcohol abuse (alcohol consumption in excess of 1 standard drink per day for women and 2 standard drinks per day for men; whereby 1 standard drink is equivalent to 12 oz beer [5% alcohol], 5 ounces of wine [12% alcohol], and 1.5 ounces of 80 proof [40% alcohol])
- Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study; or have a positive pregnancy test result at screening or check-in
- Any abnormal physical examination, vital sign, ECG, or laboratory values at screening or check-in that are considered clinically significant by the investigator
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- Special dietary requirements or restrictions and cannot follow a uniform diet
- History of febrile illness or evidence of active infection within 14 days prior to the first dose
- Any subject with SARS-CoV-2 infection, based on a rapid test or positive polymerase chain reaction for SARS-CoV-2, or subjects who received the SARS-CoV-2 vaccine within 1 month prior to the first dosing, or plans to have the vaccine within 1 month after the last dose
- Positive drug screen at screening or check-in, or has a history of drug abuse within the past 5 years
- Clinically significant interventional therapies (surgery, paracentesis, etc.) within 3 months prior to the study, or plan to have any surgeries during the study
- Blood loss of non-physiological reasons ≥ 400 mL (ie, trauma, blood collection, blood donation) within 3 months prior to the first dose of study drugs, or plan to donate blood during this study and within 1 month after the last dosing
- Currently uses more than 5 tobacco products (refer to inclusion criterion 6) per day
- Received an experimental agent (eg, vaccine, drug, biologic, device, blood product, or medication) within 3 months prior to the first dose of study drugs, or plans to receive another experimental agent during the duration of this study
- Is unwilling to abstain from alcohol-containing products and xanthine/caffeine-containing products, including any foods and beverages, within 48 hours prior to the first dose
- Used any over-the-counter medications or prescription drugs (other than hormone replacement therapy, oral contraceptives, or 650 mg acetaminophen/day), nutritional supplements, or herbal medicines within 1 month from screening, unless, in the opinion of the investigator and sponsor, the drug will not interfere with study assessments
- Abnormal renal function estimated glomerular filtration rate calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation < 90 mL/min/1.73 m2
- Abnormal QT prolongation of QTcF ≥ 450 msec for males or QTcF ≥ 470 msec for females (confirmed by repeated examination)
- History of hypokalemia or family history of long QT syndrome
- Any current or historical conditions that may interfere with the absorption/distribution/metabolism/excretion of the study drugs, in the opinion of the investigator (eg, dysphagia, gastrointestinal diseases)
- Any clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune, or dermatologic systems that would pose a risk to subject's safety or interfere with the study assessments, as determined by the investigator
- Poor venous access (eg, history of difficult blood draws) for blood sample collection or intravenous dosing
- Any other conditions that would, in the opinion of the investigator, put the subjects at increased risk for participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions
This is a Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions.The objective is To characterize the bioequivalence、safety and tolerability of TTYP01 tablets and Radicava® injection or Radicava ORS®in healthy adult subjects under fasted conditions.In this study, 30 healthy adult subjects will receive TTYP01, or Radicava, orRadicava ORS in each period according to the randomization sequence.
Read the detailed description
This is a Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions.
The Primary objective is To characterize the bioequivalence of TTYP01 tablets (Test) and Radicava® injection (Reference 1) or Radicava ORS® (Reference 2) in healthy adult subjects under fasted conditions.
The secondary objective is To determine the safety and tolerability of TTYP01 tablets (Test), Radicava Injection (Reference 1), and Radicava ORS (Reference 2) in healthy adult subjects under fasted conditions.
In this open-label, randomized, 3-formulation, 3-period, crossover study, 30 healthy adult subjects will receive 1 single oral dose of 90 mg TTYP01 (3 tablets of the test drugs, test formulation T), or 1 injection of 60 mg Radicava (reference drug R1, intravenous infusion of 60 mg administered over 60 minutes), or 1 single oral dose of 105 mg/5 mL Radicava ORS (reference drug R2) after an overnight fast in each period according to the randomization sequence. Subjects will be randomized to 1 of 6 parallel sequences (5 subjects per sequence), with a washout period of at least 96 hours between the periods.
The approximate study period is 6 weeks, including screening and follow-up.
- Conditions
- Healthy Adult Subjects
- Being tested
- TTYP01, Radicava, Radicava ORS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTYP01Drug
Also called Edaravone tablets
1 single oral dose of 90 mg TTYP01 (3 tablets of the test drugs, test formulation T)
RadicavaDrug
Also called Edaravone injection
1 injection of 60 mg Radicava (reference drug R1, intravenous infusion of 60 mg administered over 60 minutes)
Radicava ORSDrug
Also called Edaravone ORS
1 single oral dose of 105 mg/5 mL Radicava ORS (reference drug R2)
| Study group | Role | What they receive |
|---|---|---|
| TTYP01 | Active comparator | Healthy subjects were administered 1 single oral dose of 90 mg TTYP01 (3 tablets of the test drugs, test formulation T) Receives: Drug: TTYP01 |
| Radicava | Active comparator | Healthy subjects were administered 1 injection of 60 mg Radicava (reference drug R1, intravenous infusion of 60 mg administered over 60 minutes) Receives: Drug: Radicava |
| Radicava ORS | Active comparator | Healthy subjects were administered 1 single oral dose of 105 mg/5 mL Radicava ORS (reference drug R2) Receives: Drug: Radicava ORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Parameters-Area under the plasma concentration-time curve (AUC0-inf) from time 0 extrapolated to infinity of unchanged edaravone after TTYP01, Radicava and Radicava ORS administration
Measured: up to 48 hours each postdose
PK Parameters- AUC from time 0 to the last measurable non-zero concentration（AUC0-t）of unchanged edaravone after TTYP01, Radicava and Radicava ORS administration
Measured: up to 48 hours each postdose
PK Parameters - Maximum observed concentration （Cmax） of unchanged edaravone after TTYP01, Radicava and Radicava ORS administration
Measured: up to 48 hours each postdose
Secondary outcomes (12)
PK Parameters-Area under the plasma concentration-time curve (AUC0-inf) from time 0 extrapolated to infinity of sulfate and glucuronide metabolites after TTYP01, Radicava and Radicava ORS administration
Measured: up to 48 hours each postdose
PK Parameters- AUC from time 0 to the last measurable non-zero concentration（AUC0-t）of sulfate and glucuronide metabolites after TTYP01, Radicava and Radicava ORS administration
Measured: up to 48 hours each postdose
PK Parameters - Maximum observed concentration （Cmax） of sulfate and glucuronide metabolites after TTYP01, Radicava and Radicava ORS administration
Measured: up to 48 hours each postdose
PK Parameters- Time to reach Cmax （Tmax）of unchanged edaravone, sulfate, and glucuronide metabolites after TTYP01, Radicava, and Radicava ORS administration
Measured: up to 48 hours each postdose
PK Parameters - Apparent terminal elimination half-life （T1/2el）of unchanged edaravone, sulfate, and glucuronide metabolites after TTYP01, Radicava, and Radicava ORS administration
Measured: up to 48 hours each postdose
PK Parameters - Apparent terminal elimination rate constant （Kel）of unchanged edaravone, sulfate and glucuronide metabolites after TTYP01, Radicava and Radicava ORS administration
Measured: up to 48 hours each postdose
PK Parameters -Apparent oral drug clearance (parent drug only) （CL/F）of unchanged edaravone after TTYP01and Radicava ORS administration
Measured: up to 48 hours each postdose
PK Parameters - Total clearance (CL) of unchanged edaravone after Radicava administration
Measured: up to 48 hours each postdose
PK Parameters - Mean residence time (MRT）of unchanged edaravone after Radicava administration
Measured: up to 48 hours each postdose
PK Parameters -Apparent volume of distribution Vz/F） of unchanged edaravone after TTYP01and Radicava ORS administration
Measured: up to 48 hours each postdose
PK Parameters - Volume of distribution during terminal phase (Vz) of unchanged edaravone after Radicava administration
Measured: up to 48 hours each postdose
Incidence and Number of Participants with Adverse events and adverse drug reactions
Measured: until the last follow-up visit, up to 6 weeks(including screening and follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start7 Nov 2023
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Auzone Biological Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert. Bass, MD, Principal investigator, ICON plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107205
- Sponsor's protocol ID
- TTYP01-02-2022
- Status last verified
- Apr 2026
- First submitted
- 16 Oct 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06107205
- Acronym / sponsor ID
- TTYP01-02-2022
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Shanghai Auzone Biological Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 30 Oct 2023 (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 Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions.The objective is To characterize the bioequivalence、safety and tolerability of TTYP01 tablets and Radicava® injection or Radicava ORS®in healthy adult subjects under fasted conditions.In this study, 30 healthy adult subjects will receive TTYP01, or Radicava, orRadicava ORS in each period according to the randomization sequence.
Detailed description
This is a Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions.
The Primary objective is To characterize the bioequivalence of TTYP01 tablets (Test) and Radicava® injection (Reference 1) or Radicava ORS® (Reference 2) in healthy adult subjects under fasted conditions.
The secondary objective is To determine the safety and tolerability of TTYP01 tablets (Test), Radicava Injection (Reference 1), and Radicava ORS (Reference 2) in healthy adult subjects under fasted conditions.
In this open-label, randomized, 3-formulation, 3-period, crossover study, 30 healthy adult subjects will receive 1 single oral dose of 90 mg TTYP01 (3 tablets of the test drugs, test formulation T), or 1 injection of 60 mg Radicava (reference drug R1, intravenous infusion of 60 mg administered over 60 minutes), or 1 single oral dose of 105 mg/5 mL Radicava ORS (reference drug R2) after an overnight fast in each period according to the randomization sequence. Subjects will be randomized to 1 of 6 parallel sequences (5 subjects per sequence), with a washout period of at least 96 hours between the periods.
The approximate study period is 6 weeks, including screening and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TTYP01 | Active comparator | Drug: TTYP01Healthy subjects were administered 1 single oral dose of 90 mg TTYP01 (3 tablets of the test drugs, test formulation T) |
| Radicava | Active comparator | Drug: RadicavaHealthy subjects were administered 1 injection of 60 mg Radicava (reference drug R1, intravenous infusion of 60 mg administered over 60 minutes) |
| Radicava ORS | Active comparator | Drug: Radicava ORSHealthy subjects were administered 1 single oral dose of 105 mg/5 mL Radicava ORS (reference drug R2) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (27 listed)
- Subjects must meet all inclusion criteria at screening (or as noted) to be eligible for study participation, as follows:
- Informed consent signed and dated by the subject
- Healthy male and female subjects of any ethnic and racial origin, aged 20 to 45 years, inclusive
- Female subjects who:
- Male subjects who are sexually active and whose partners are females of child-bearing potential, even if surgically sterilized (ie, status post vasectomy), who:
Key exclusion criteria (23 listed)
- Subjects will not be eligible for study participation if they meet any of the exclusion criteria at screening (or as noted), or will be discontinued at the discretion of the investigator in consultation with the medical monitor if they develop any of the exclusion criteria during the study.
- History of any hypersensitivity or allergic reaction to active ingredients or excipients of the study drugs (eg, known allergy to bisulfite containing foods such as bottled lemon juice, grape juice, canned fruits, wine, jam, jelly, etc.)
- Positive test result for infectious diseases at screening or baseline, including human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C virus antibody, and syphilis antibody
- Positive alcohol test at screening or baseline, or has a history of alcohol abuse (alcohol consumption in excess of 1 standard drink per day for women and 2 standard drinks per day for men; whereby 1 standard drink is equivalent to 12 oz beer [5% alcohol], 5 ounces of wine [12% alcohol], and 1.5 ounces of 80 proof [40% alcohol])
- Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study; or have a positive pregnancy test result at screening or check-in
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 |
|---|---|---|
| TTYP01Also: Edaravone tablets1 single oral dose of 90 mg TTYP01 (3 tablets of the test drugs, test formulation T) | Drug | TTYP01 |
| RadicavaAlso: Edaravone injection1 injection of 60 mg Radicava (reference drug R1, intravenous infusion of 60 mg administered over 60 minutes) | Drug | Radicava |
| Radicava ORSAlso: Edaravone ORS1 single oral dose of 105 mg/5 mL Radicava ORS (reference drug R2) | Drug | Radicava ORS |
Primary outcome
PK Parameters-Area under the plasma concentration-time curve (AUC0-inf) from time 0 extrapolated to infinity of unchanged edaravone after TTYP01, Radicava and Radicava ORS administration
Time frame: up to 48 hours each postdose
PK Parameters- AUC from time 0 to the last measurable non-zero concentration（AUC0-t）of unchanged edaravone after TTYP01, Radicava and Radicava ORS administration
Time frame: up to 48 hours each postdose
PK Parameters - Maximum observed concentration （Cmax） of unchanged edaravone after TTYP01, Radicava and Radicava ORS administration
Time frame: up to 48 hours each postdose
12 secondary outcomes
PK Parameters-Area under the plasma concentration-time curve (AUC0-inf) from time 0 extrapolated to infinity of sulfate and glucuronide metabolites after TTYP01, Radicava and Radicava ORS administration
Time frame: up to 48 hours each postdose
PK Parameters- AUC from time 0 to the last measurable non-zero concentration（AUC0-t）of sulfate and glucuronide metabolites after TTYP01, Radicava and Radicava ORS administration
Time frame: up to 48 hours each postdose
PK Parameters - Maximum observed concentration （Cmax） of sulfate and glucuronide metabolites after TTYP01, Radicava and Radicava ORS administration
Time frame: up to 48 hours each postdose
PK Parameters- Time to reach Cmax （Tmax）of unchanged edaravone, sulfate, and glucuronide metabolites after TTYP01, Radicava, and Radicava ORS administration
Time frame: up to 48 hours each postdose
PK Parameters - Apparent terminal elimination half-life （T1/2el）of unchanged edaravone, sulfate, and glucuronide metabolites after TTYP01, Radicava, and Radicava ORS administration
Time frame: up to 48 hours each postdose
PK Parameters - Apparent terminal elimination rate constant （Kel）of unchanged edaravone, sulfate and glucuronide metabolites after TTYP01, Radicava and Radicava ORS administration
Time frame: up to 48 hours each postdose
PK Parameters -Apparent oral drug clearance (parent drug only) （CL/F）of unchanged edaravone after TTYP01and Radicava ORS administration
Time frame: up to 48 hours each postdose
PK Parameters - Total clearance (CL) of unchanged edaravone after Radicava administration
Time frame: up to 48 hours each postdose
PK Parameters - Mean residence time (MRT）of unchanged edaravone after Radicava administration
Time frame: up to 48 hours each postdose
PK Parameters -Apparent volume of distribution Vz/F） of unchanged edaravone after TTYP01and Radicava ORS administration
Time frame: up to 48 hours each postdose
PK Parameters - Volume of distribution during terminal phase (Vz) of unchanged edaravone after Radicava administration
Time frame: up to 48 hours each postdose
Incidence and Number of Participants with Adverse events and adverse drug reactions
Time frame: until the last follow-up visit, up to 6 weeks(including screening and follow-up)
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 24 Apr 2026.
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Healthy Subjects
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.
Robert. Bass, MD principal investigator
ICON plc
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 TTYP01, Radicava and Radicava ORS in people with Healthy Adult Subjects, run by Shanghai Auzone Biological Technology Co., Ltd. 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 27 inclusion and 23 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 24 Apr 2026. 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?
PK Parameters-Area under the plasma concentration-time curve (AUC0-inf) from time 0 extrapolated to infinity of unchanged edaravone after TTYP01, Radicava and Radicava ORS administration (time frame: up to 48 hours each postdose). The study lists 3 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 24 Apr 2026.