Healthy Adult SubjectsPhase 1NCT04370431
A Study of TTYP01 in Healthy Adult Subjects
A Phase 1 study testing TTYP01 single ascending doses, TTYP01, 60 mg and TTYP01, 120 mg in people with Healthy Adult Subjects, run by Shanghai Auzone Biological Technology Co., Ltd. at 1 site in Australia.
Trial summary
This is integrated Phase 1, Single centre, Randomized study will be conducted in 3 parts, each with a specific primary objective: Part A: To characterise the safety and tolerability of TTYP01 in healthy adult subjects; Part B: To evaluate the bioavailability of TTYP01 tablets in healthy adult subjects; Part C: To… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- TTYP01 single ascending doses, TTYP01, 60 mg and TTYP01, 120 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Apr 2020to 8 Jan 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40, inclusive;
- Non-smokers, ex-smokers and moderate smokers will be included. "A moderate smoker is defined as someone smoking 5 cigarettes or less per day, an ex-smoker is someone who completely stopped smoking for at least 3 months.";
- If female, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception (e.g., oral, intrauterine device [IUD; diaphragm], injectable, transdermal or implantable contraception) or abstinence, for at least 1 month prior to randomization, during the study and 3 month following completion of the study. Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening;
- Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive; and a total body weight >50 kg at screening for male subjects, total body weight > 45 kg for female subjects;
- Female subjects of child bearing potential and all male participants who have not had a vasectomy must use effective contraception during the study
- Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the subject prior to any study-specific procedures), and evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
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- Willingness and ability to comply with study procedures and follow-up examination.
- Adequate organ function as evidenced by the following peripheral blood counts or serum chemistry values within 28 days before randomization:
- Hemoglobin greater than or equal to 9 g/dL
- Neutrophil count (ANC) greater than or equal to 1,500/microL
- Platelet count greater than or equal to 100,000/microL
- Serum creatinine less than or equal to 1.5 mg/dL (less than or equal to 132.6 micromol/L) and creatinine clearance greater than or equal to 60 ml/min
- Creatine phosphokinase (CPK) less than or equal to 2x upper limit of normal (ULN)
- Hepatic function variables:
- Total bilirubin ≤ 1.5x ULN
- Total alkaline phosphatase (ALP) ≤ 1.5x ULN, or if > 1.5x ULN, then ALP liver fraction or 5' nucleotidase must be ≤1x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be ≤ 2.5x ULN
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- Subjects with a history of hypersensitivity to edaravone or any of the inactive ingredients of the formulation (such as sulfite and sodium bisulfite).
- Subjects with PR >240 msec, QRS =120 msec, or QTcF >450 msec for male \& QTcF >470 msec for female on the screening or Day -1 ECG, or any clinically significant electrocardiographic abnormality in the opinion of the investigator.
- Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 3 months after the last dose of investigational product.
- Female subjects currently pregnant or lactating; female subjects able to bear children or of child bearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 3 months after the last dose of investigational product.
- Subjects whose urine drug/alcohol screening was positive at the time of screening and/or on Day-1.
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- Subjects having difficulty in swallowing pills/tablets.
- Subjects smoking > 5 cigarettes per day within 3 months prior to the screening visit.
- Subjects unwilling or unable to comply with the Lifestyle Guidelines described in the protocol.
- Subjects who are investigational site staff members directly involved in the conduct of the studies and their family members, site staff members otherwise supervised by the Investigator, or subjects who are the sponsors' employees directly involved in the conduct of the studies.
- Evidence of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
- Subjects who have participated in another clinical trial less than 3 months before or donated his/her blood in a quantity greater than 200 milliliters (mL) within 1 month of the screening period of this clinical trial.
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
About this study
Official title: A Phase I, Single Center, Randomized, Single-Ascending Dose, Pharmacokinetic and Safety Study (Part A), Bioavailability Comparison Study (Part B) and Food Effect Study (Part C) in Healthy Adult Subjects.
This is integrated Phase 1, Single centre, Randomized study will be conducted in 3 parts, each with a specific primary objective:
Part A: To characterise the safety and tolerability of TTYP01 in healthy adult subjects; Part B: To evaluate the bioavailability of TTYP01 tablets in healthy adult subjects; Part C: To characterise the food effect of TTYP01 tablets in healthy adult subjects under the fasted or fed condition.
The secondary objectives of the study are to evaluate the pharmacokinetic (PK) profiles of TTYP01 tablets in healthy adult subjects, and the effects of gender on the PK of TTYP01 tablets in healthy adults. In Part A of the study, a total of 32 healthy adult subjects will be enrolled over four consecutive cohorts (8 per cohort), with participants receiving a single dose of TTYP01 at one of four levels (60, 120, 10 or 240 mg), to assess the PK and safety of TTYP01. In Part B, 16 healthy adults will be randomized into 2 groups, and the comparison of the PK of edaravone (TTYP01 and intravenous (IV) edaravone) will be evaluated using a randomized, open-label, four-period crossover design under fasted conditions. In the first crossover period, subjects will receive a single fixed dose of TTYP01 followed by the alternate IV dose after completion of the washout phase, and in the second crossover period, subjects will receive a higher fixed dose of TTYP01 followed by the alternate IV dose after completion of the washout phase. In Part C, 18 healthy subjects will be enrolled to evaluate the effect of food on the PK of TTYP01 using a randomized, open-label, two-period cross-over design. Participants will be randomized into two groups and administered a fixed dose of TTYP01 on Day 1 (Period 1) under the fed conditions and the second dosing day (Period 2) under the fasted conditions, while the other group being administered a fixed dose of TTYP01 on Day 1 (Period 1) under the fasted conditions and the second dosing day (Period 2) under the fed conditions.
- Conditions
- Healthy Adult Subjects
- Being tested
- TTYP01 single ascending doses, Placebo, TTYP01, 60 mg, TTYP01, 120 mg, Radicut® (ampoule), 30 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTYP01 single ascending dosesDrug
Also called edaravone tablet
TTYP01 (30 mg edaravone tablet) will be orally administrated at single ascending doses of 60 mg, 120 mg, 180 mg and 240 mg (n=6 per dose)
PlaceboDrug
Placebo control for Part A of the study
TTYP01, 60 mgDrug
Also called Edaravone tablet
TTYP01 oral tablets (30 mg edaravone per tablet)
TTYP01, 120 mgDrug
Also called Edaravone tablet
TTYP01 oral tablets (30 mg edaravone per tablet)
Radicut® (ampoule), 30 mgDrug
Also called Edaravone injection
An intravenous dose of edaravone injection, containing 30 mg edaravone in a 20 mL ampoule, will be administered at a dose of 30 mg over 30 minutes
Radicut® (bag) , 60 mgDrug
Also called Edaravone injection
An intravenous dose of edaravone injection, containing 30 mg edaravone in a 100 mL injection bag, will be administered at a dose of 60 mg over 60 minutes
TTYP01, up to 120 mgDrug
Also called Edaravone tablet
TTYP01 oral tablets (30 mg edaravone per tablet). The fixed oral dose level of TTYP01 will depend on the results obtained in Part B of the study (no more than 120 mg)
| Study group | Role | What they receive |
|---|---|---|
| PartA: TTYP01 single ascending doses | Experimental | In Part A: a single-ascending-dose (SAD) escalation study with four consecutive cohorts, single ascending doses of TTYP01 (60, 120, 180 and 240 mg) will be orally administrated. Receives: Drug: TTYP01 single ascending doses |
| Part A: Placebo | Placebo comparator | Placebo control for Part A of the study Receives: Drug: Placebo |
| Part B: TTYP01 (oral edaravone) first then IV edaravone | Experimental | Randomized, Open-label, Four-period and Crossover design. A single dose of edaravone in each treatment period. Period 1: 60 mg oral edaravone tablet (TTYP01); Period 2: 30 mg IV edaravone (Radicut® ampoule), Period 3: 120 mg oral edaravone tablet (TTYP01); Period 4: 60 mg IV edaravone (Radicut® bag). Each dose will be spearated by a minimum of 7 days washout period. Receives: Drug: TTYP01, 60 mg; Drug: TTYP01, 120 mg; Drug: Radicut® (ampoule), 30 mg; Drug: Radicut® (bag) , 60 mg |
| Part B: IV edaravone first then TTYP01 (oral edaravone) | Experimental | Randomized, Open-label, Four-period and Crossover design. A single dose of edaravone in each treatment period. Period 1: 30 mg IV edaravone (Radicut® ampoule); Period 2: 60 mg oral edaravone tablet (TTYP01); Period 3: 60 mg IV edaravone (Radicut® bag); Period 4: 120 mg oral edaravone tablet (TTYP01). Each dose will be spearated by a minimum of 7 days washout period. Receives: Drug: TTYP01, 60 mg; Drug: TTYP01, 120 mg; Drug: Radicut® (ampoule), 30 mg; Drug: Radicut® (bag) , 60 mg |
| Part C: TTYP01: fasted dosing first then fed dosing | Experimental | Randomized, open-Label, Two-period and Crossover design. A fix oral dose of TTYP01 tablet in each treatment period. Period 1: under fasted condition; Period 2: under fed condition. Each dose will be spearated by a minimum of 7 days washout period. Receives: Drug: TTYP01, up to 120 mg |
| Part C: TTYP01: fed dosing first then fasted dosing | Experimental | Randomized, open-Label, Two-period and Crossover design. A fix oral dose of TTYP01 tablet in each treatment period. Period 1: under fed condition; Period 2: under fasted condition. Each dose will be spearated by a minimum of 7 days washout period. Receives: Drug: TTYP01, up to 120 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Frequencies (number and percentage) of subjects with one or more AEs
Measured: until the last follow-up visit, up to 4 weeks
change in hemoglobin (g/L)
measured by hematology test
Measured: up to 6 days post each dose
change in hematocrit (ratio)
measured by hematology test
Measured: up to 6 days post each dose
change in red blood cell count (cells x 10^12/L)
measured by hematology test
Measured: up to 6 days post each dose
change in white blood cell (WBC) count (cells x 10^9/L)
measured by hematology test
Measured: up to 6 days post each dose
change in platelet count (cells x 10^9/L)
measured by hematology test
Measured: up to 6 days post each dose
change in total neutrophils count (cells x 10^9/L)
measured by hematology test
Measured: up to 6 days post each dose
change in lymphocytes count (cells x 10^9/L)
measured by hematology test
Measured: up to 6 days post each dose
change in monocytes count (cells x 10^9/L)
measured by hematology test
Measured: up to 6 days post each dose
change in eosinophils count (cells x 10^9/L)
measured by hematology test
Measured: up to 6 days post each dose
change in basophils count (cells x 10^9/L)
measured by hematology test
Measured: up to 6 days post each dose
change in serum sodium (mmol/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in serum potassium (mmol/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in serum chloride (mmol/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in serum calcium (mmol/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in serum glucose (mmol/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in serum urea (mmol/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in serum creatinine (umol/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in serum total bilirubin (umol/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in aspartate aminotransferase (AST) (U/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in alanine aminotransferase (ALT) (U/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in alkaline phosphatase (ALP) (U/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in serum creatine kinase (CK) (U/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in serum albumin (g/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in serum phosphate (mmol/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in serum lipase (U/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in serum total protein (g/L)
measured by serum chemistry
Measured: up to 6 days post each dose
change in urine pH
measured by urinalysis
Measured: up to 6 days post each dose
change in urine specific gravity
measured by urinalysis
Measured: up to 6 days post each dose
change in urine glucose
measured by urinalysis
Measured: up to 6 days post each dose
change in urine protein
measured by urinalysis
Measured: up to 6 days post each dose
change in urine ketones
measured by urinalysis
Measured: up to 6 days post each dose
change in urine blood
measured by urinalysis
Measured: up to 6 days post each dose
change in urine casts
measured by microscopic analysis, if any abnormalities in urinalysis are detected
Measured: up to 6 days post each dose
change in urine crystals
measured by microscopic analysis, if any abnormalities in urinalysis are detected
Measured: up to 6 days post each dose
change in urine epithelial cells
measured by microscopic analysis, if any abnormalities in urinalysis are detected
Measured: up to 6 days post each dose
change in urine bacteria (cfu/L)
measured by microscopic analysis, if any abnormalities in urinalysis are detected
Measured: up to 6 days post each dose
change in urine red blood cells (Cells x 10^9/L)
measured by microscopic analysis, if any abnormalities in urinalysis are detected
Measured: up to 6 days post each dose
change in urine white blood cells (Cells x 10^9/L)
measured by microscopic analysis, if any abnormalities in urinalysis are detected
Measured: up to 6 days post each dose
change in systolic blood pressure (mmHg)
Measured: up to 6 days post each dose
change in diastolic blood pressure (mmHg)
Measured: up to 6 days post each dose
change in pulse rate (bpm)
Measured: up to 6 days post each dose
change in body temperature (celsius)
Measured: up to 6 days post each dose
Change in QT intervals (msec)
Measured using a 12 Lead Electrocardiogram
Measured: up to 6 days post each dose
Change in RR intervals (msec)
Measured using a 12 Lead Electrocardiogram
Measured: up to 6 days post each dose
Change in PR intervals (msec)
Measured using a 12 Lead Electrocardiogram
Measured: up to 6 days post each dose
Change in QRS duration (msec)
Measured using a 12 Lead Electrocardiogram
Measured: up to 6 days post each dose
Change in corrected QTcF (msec)
Calculated using measurements by a 12 Lead Electrocardiogram
Measured: up to 6 days post each dose
clinically significant abnormality in brief physical examinations
clinically significant abnormality in skin, lungs, cardiovascular system, and abdomen (spleen and liver)
Measured: up to 6 days post each dose
Secondary outcomes (11)
Maximum observed plasma concentration (Cmax)
Measured: up to 24 hours post each dose
Time of maximum plasma concentration (Tmax)
Measured: up to 24 hours post each dose
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
Measured: up to 24 hours post each dose
Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last)
Measured: up to 24 hours post each dose
The ratio of area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last) extrapolated to AUC0-inf over AUC0-inf (% AUCex)
Measured: up to 24 hours post each dose
Apparent volume of distribution (Vd/F)
Measured: up to 24 hours post each dose
Terminal half-life(T1/2)
Measured: up to 24 hours post each dose
Apparent oral clearance (CL/F)
Measured: up to 24 hours post each dose
Mean retention time (MRT)
Measured: up to 24 hours post each dose
Lambda z - the reciprocal of elimination rate constant (λz)
Measured: up to 24 hours post each dose
Fabs-bioavailability value (Fabs)
Measured: up to 24 hours post each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start24 Apr 2020
- Primary completion17 Dec 2020
- Study completion8 Jan 2021
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Auzone Biological Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TIGERMED AUSTRALIA PTY LIMITED, CMAX Clinical Research Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Sepehr Shakib, MD, Principal investigator, Royal Adelaide Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370431
- Sponsor's protocol ID
- Auzone-01
- Status last verified
- Mar 2021
- First submitted
- 18 Apr 2020
- Last updated
- 6 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Center, Randomized, Single-Ascending Dose, Pharmacokinetic and Safety Study (Part A), Bioavailability Comparison Study (Part B) and Food Effect Study (Part C) in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT04370431
- Acronym / sponsor ID
- Auzone-01
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shanghai Auzone Biological Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- TIGERMED AUSTRALIA PTY LIMITED, CMAX Clinical Research Pty Ltd
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 1 May 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.
This is integrated Phase 1, Single centre, Randomized study will be conducted in 3 parts, each with a specific primary objective:
Part A: To characterise the safety and tolerability of TTYP01 in healthy adult subjects; Part B: To evaluate the bioavailability of TTYP01 tablets in healthy adult subjects; Part C: To characterise the food effect of TTYP01 tablets in healthy adult subjects under the fasted or fed condition.
The secondary objectives of the study are to evaluate the pharmacokinetic (PK) profiles of TTYP01 tablets in healthy adult subjects, and the effects of gender on the PK of TTYP01 tablets in healthy adults. In Part A of the study, a total of 32 healthy adult subjects will be enrolled over four consecutive cohorts (8 per cohort), with participants receiving a single dose of TTYP01 at one of four levels (60, 120, 10 or 240 mg), to assess the PK and safety of TTYP01. In Part B, 16 healthy adults will be randomized into 2 groups, and the comparison of the PK of edaravone (TTYP01 and intravenous (IV) edaravone) will be evaluated using a randomized, open-label, four-period crossover design under fasted conditions. In the first crossover period, subjects will receive a single fixed dose of TTYP01 followed by the alternate IV dose after completion of the washout phase, and in the second crossover period, subjects will receive a higher fixed dose of TTYP01 followed by the alternate IV dose after completion of the washout phase. In Part C, 18 healthy subjects will be enrolled to evaluate the effect of food on the PK of TTYP01 using a randomized, open-label, two-period cross-over design. Participants will be randomized into two groups and administered a fixed dose of TTYP01 on Day 1 (Period 1) under the fed conditions and the second dosing day (Period 2) under the fasted conditions, while the other group being administered a fixed dose of TTYP01 on Day 1 (Period 1) under the fasted conditions and the second dosing day (Period 2) under the fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PartA: TTYP01 single ascending doses | Experimental | Drug: TTYP01 single ascending dosesIn Part A: a single-ascending-dose (SAD) escalation study with four consecutive cohorts, single ascending doses of TTYP01 (60, 120, 180 and 240 mg) will be orally administrated. |
| Part A: Placebo | Placebo comparator | Drug: PlaceboPlacebo control for Part A of the study |
| Part B: TTYP01 (oral edaravone) first then IV edaravone | Experimental | Drug: TTYP01, 60 mg, Drug: TTYP01, 120 mg, Drug: Radicut® (ampoule), 30 mg, Drug: Radicut® (bag) , 60 mgRandomized, Open-label, Four-period and Crossover design. A single dose of edaravone in each treatment period. Period 1: 60 mg oral edaravone tablet (TTYP01); Period 2: 30 mg IV edaravone (Radicut® ampoule), Period 3: 120 mg oral edaravone tablet (TTYP01); Period 4: 60 mg IV edaravone (Radicut® bag). Each dose will be spearated by a minimum of 7 days washout period. |
| Part B: IV edaravone first then TTYP01 (oral edaravone) | Experimental | Drug: TTYP01, 60 mg, Drug: TTYP01, 120 mg, Drug: Radicut® (ampoule), 30 mg, Drug: Radicut® (bag) , 60 mgRandomized, Open-label, Four-period and Crossover design. A single dose of edaravone in each treatment period. Period 1: 30 mg IV edaravone (Radicut® ampoule); Period 2: 60 mg oral edaravone tablet (TTYP01); Period 3: 60 mg IV edaravone (Radicut® bag); Period 4: 120 mg oral edaravone tablet (TTYP01). Each dose will be spearated by a minimum of 7 days washout period. |
| Part C: TTYP01: fasted dosing first then fed dosing | Experimental | Drug: TTYP01, up to 120 mgRandomized, open-Label, Two-period and Crossover design. A fix oral dose of TTYP01 tablet in each treatment period. Period 1: under fasted condition; Period 2: under fed condition. Each dose will be spearated by a minimum of 7 days washout period. |
| Part C: TTYP01: fed dosing first then fasted dosing | Experimental | Drug: TTYP01, up to 120 mgRandomized, open-Label, Two-period and Crossover design. A fix oral dose of TTYP01 tablet in each treatment period. Period 1: under fed condition; Period 2: under fasted condition. Each dose will be spearated by a minimum of 7 days washout period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Age between 18 and 40, inclusive;
- Non-smokers, ex-smokers and moderate smokers will be included. "A moderate smoker is defined as someone smoking 5 cigarettes or less per day, an ex-smoker is someone who completely stopped smoking for at least 3 months.";
- If female, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception (e.g., oral, intrauterine device [IUD; diaphragm], injectable, transdermal or implantable contraception) or abstinence, for at least 1 month prior to randomization, during the study and 3 month following completion of the study. Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening;
- Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive; and a total body weight >50 kg at screening for male subjects, total body weight > 45 kg for female subjects;
- Female subjects of child bearing potential and all male participants who have not had a vasectomy must use effective contraception during the study
Key exclusion criteria (12 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- Subjects with a history of hypersensitivity to edaravone or any of the inactive ingredients of the formulation (such as sulfite and sodium bisulfite).
- Subjects with PR >240 msec, QRS =120 msec, or QTcF >450 msec for male \& QTcF >470 msec for female on the screening or Day -1 ECG, or any clinically significant electrocardiographic abnormality in the opinion of the investigator.
- Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 3 months after the last dose of investigational product.
- Female subjects currently pregnant or lactating; female subjects able to bear children or of child bearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 3 months after the last dose of investigational product.
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 |
|---|---|---|
| TTYP01 single ascending dosesAlso: edaravone tabletTTYP01 (30 mg edaravone tablet) will be orally administrated at single ascending doses of 60 mg, 120 mg, 180 mg and 240 mg (n=6 per dose) | Drug | PartA: TTYP01 single ascending doses |
| PlaceboPlacebo control for Part A of the study | Drug | Part A: Placebo |
| TTYP01, 60 mgAlso: Edaravone tabletTTYP01 oral tablets (30 mg edaravone per tablet) | Drug | Part B: IV edaravone first then TTYP01 (oral edaravone), Part B: TTYP01 (oral edaravone) first then IV edaravone |
| TTYP01, 120 mgAlso: Edaravone tabletTTYP01 oral tablets (30 mg edaravone per tablet) | Drug | Part B: IV edaravone first then TTYP01 (oral edaravone), Part B: TTYP01 (oral edaravone) first then IV edaravone |
| Radicut® (ampoule), 30 mgAlso: Edaravone injectionAn intravenous dose of edaravone injection, containing 30 mg edaravone in a 20 mL ampoule, will be administered at a dose of 30 mg over 30 minutes | Drug | Part B: IV edaravone first then TTYP01 (oral edaravone), Part B: TTYP01 (oral edaravone) first then IV edaravone |
| Radicut® (bag) , 60 mgAlso: Edaravone injectionAn intravenous dose of edaravone injection, containing 30 mg edaravone in a 100 mL injection bag, will be administered at a dose of 60 mg over 60 minutes | Drug | Part B: IV edaravone first then TTYP01 (oral edaravone), Part B: TTYP01 (oral edaravone) first then IV edaravone |
| TTYP01, up to 120 mgAlso: Edaravone tabletTTYP01 oral tablets (30 mg edaravone per tablet). The fixed oral dose level of TTYP01 will depend on the results obtained in Part B of the study (no more than 120 mg) | Drug | Part C: TTYP01: fasted dosing first then fed dosing, Part C: TTYP01: fed dosing first then fasted dosing |
Primary outcome
Adverse events
Time frame: until the last follow-up visit, up to 4 weeks
Frequencies (number and percentage) of subjects with one or more AEs
change in hemoglobin (g/L)
Time frame: up to 6 days post each dose
measured by hematology test
change in hematocrit (ratio)
Time frame: up to 6 days post each dose
measured by hematology test
change in red blood cell count (cells x 10^12/L)
Time frame: up to 6 days post each dose
measured by hematology test
change in white blood cell (WBC) count (cells x 10^9/L)
Time frame: up to 6 days post each dose
measured by hematology test
change in platelet count (cells x 10^9/L)
Time frame: up to 6 days post each dose
measured by hematology test
change in total neutrophils count (cells x 10^9/L)
Time frame: up to 6 days post each dose
measured by hematology test
change in lymphocytes count (cells x 10^9/L)
Time frame: up to 6 days post each dose
measured by hematology test
change in monocytes count (cells x 10^9/L)
Time frame: up to 6 days post each dose
measured by hematology test
change in eosinophils count (cells x 10^9/L)
Time frame: up to 6 days post each dose
measured by hematology test
change in basophils count (cells x 10^9/L)
Time frame: up to 6 days post each dose
measured by hematology test
change in serum sodium (mmol/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in serum potassium (mmol/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in serum chloride (mmol/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in serum calcium (mmol/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in serum glucose (mmol/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in serum urea (mmol/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in serum creatinine (umol/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in serum total bilirubin (umol/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in aspartate aminotransferase (AST) (U/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in alanine aminotransferase (ALT) (U/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in alkaline phosphatase (ALP) (U/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in serum creatine kinase (CK) (U/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in serum albumin (g/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in serum phosphate (mmol/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in serum lipase (U/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in serum total protein (g/L)
Time frame: up to 6 days post each dose
measured by serum chemistry
change in urine pH
Time frame: up to 6 days post each dose
measured by urinalysis
change in urine specific gravity
Time frame: up to 6 days post each dose
measured by urinalysis
change in urine glucose
Time frame: up to 6 days post each dose
measured by urinalysis
change in urine protein
Time frame: up to 6 days post each dose
measured by urinalysis
change in urine ketones
Time frame: up to 6 days post each dose
measured by urinalysis
change in urine blood
Time frame: up to 6 days post each dose
measured by urinalysis
change in urine casts
Time frame: up to 6 days post each dose
measured by microscopic analysis, if any abnormalities in urinalysis are detected
change in urine crystals
Time frame: up to 6 days post each dose
measured by microscopic analysis, if any abnormalities in urinalysis are detected
change in urine epithelial cells
Time frame: up to 6 days post each dose
measured by microscopic analysis, if any abnormalities in urinalysis are detected
change in urine bacteria (cfu/L)
Time frame: up to 6 days post each dose
measured by microscopic analysis, if any abnormalities in urinalysis are detected
change in urine red blood cells (Cells x 10^9/L)
Time frame: up to 6 days post each dose
measured by microscopic analysis, if any abnormalities in urinalysis are detected
change in urine white blood cells (Cells x 10^9/L)
Time frame: up to 6 days post each dose
measured by microscopic analysis, if any abnormalities in urinalysis are detected
change in systolic blood pressure (mmHg)
Time frame: up to 6 days post each dose
change in diastolic blood pressure (mmHg)
Time frame: up to 6 days post each dose
change in pulse rate (bpm)
Time frame: up to 6 days post each dose
change in body temperature (celsius)
Time frame: up to 6 days post each dose
Change in QT intervals (msec)
Time frame: up to 6 days post each dose
Measured using a 12 Lead Electrocardiogram
Change in RR intervals (msec)
Time frame: up to 6 days post each dose
Measured using a 12 Lead Electrocardiogram
Change in PR intervals (msec)
Time frame: up to 6 days post each dose
Measured using a 12 Lead Electrocardiogram
Change in QRS duration (msec)
Time frame: up to 6 days post each dose
Measured using a 12 Lead Electrocardiogram
Change in corrected QTcF (msec)
Time frame: up to 6 days post each dose
Calculated using measurements by a 12 Lead Electrocardiogram
clinically significant abnormality in brief physical examinations
Time frame: up to 6 days post each dose
clinically significant abnormality in skin, lungs, cardiovascular system, and abdomen (spleen and liver)
11 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: up to 24 hours post each dose
Time of maximum plasma concentration (Tmax)
Time frame: up to 24 hours post each dose
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
Time frame: up to 24 hours post each dose
Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last)
Time frame: up to 24 hours post each dose
The ratio of area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-last) extrapolated to AUC0-inf over AUC0-inf (% AUCex)
Time frame: up to 24 hours post each dose
Apparent volume of distribution (Vd/F)
Time frame: up to 24 hours post each dose
Terminal half-life(T1/2)
Time frame: up to 24 hours post each dose
Apparent oral clearance (CL/F)
Time frame: up to 24 hours post each dose
Mean retention time (MRT)
Time frame: up to 24 hours post each dose
Lambda z - the reciprocal of elimination rate constant (λz)
Time frame: up to 24 hours post each dose
Fabs-bioavailability value (Fabs)
Time frame: up to 24 hours post each dose
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 6 Jan 2025.
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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.
Sepehr Shakib, MD principal investigator
Royal Adelaide Hospital
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 single ascending doses, TTYP01, 60 mg and TTYP01, 120 mg in people with Healthy Adult Subjects, run by Shanghai Auzone Biological Technology Co., Ltd. at 1 site in Australia.
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 17 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 6 Jan 2025. 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 Australia. 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?
Adverse events (time frame: until the last follow-up visit, up to 4 weeks). The study lists 49 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 6 Jan 2025.