Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects

NCT06107205 | Completed Phase 1 FDA Drug

• 1 other identifier: TTYP01-02-2022
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (3)

• 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

  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

  up to 48 hours each postdose

• PK Parameters - Maximum observed concentration （Cmax） of unchanged edaravone after TTYP01, Radicava and Radicava ORS administration

  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

  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

  up to 48 hours each postdose

• PK Parameters - Maximum observed concentration （Cmax） of sulfate and glucuronide metabolites after TTYP01, Radicava and Radicava ORS administration

  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

  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

  up to 48 hours each postdose

Study Arms (3)

TTYP01

ACTIVE COMPARATOR

Healthy subjects were administered 1 single oral dose of 90 mg TTYP01 (3 tablets of the test drugs, test formulation T)

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)

Drug: Radicava

Radicava ORS

ACTIVE COMPARATOR

Healthy subjects were administered 1 single oral dose of 105 mg/5 mL Radicava ORS (reference drug R2)

Drug: Radicava ORS

Interventions

TTYP01 DRUG

1 single oral dose of 90 mg TTYP01 (3 tablets of the test drugs, test formulation T)

Also known as: Edaravone tablets

TTYP01

Radicava DRUG

1 injection of 60 mg Radicava (reference drug R1, intravenous infusion of 60 mg administered over 60 minutes)

Also known as: Edaravone injection

Radicava

Radicava ORS DRUG

1 single oral dose of 105 mg/5 mL Radicava ORS (reference drug R2)

Also known as: Edaravone ORS

Radicava ORS

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Shanghai Auzone Biological Technology Co., Ltd.: lead

Study Sites (1)

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

Edaravone

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert. Bass, MD

  ICON plc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 30, 2023
• Study Start: November 7, 2023
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)