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Bioequivalence Study for TTYP01 in Healthy Adults

Phase 1
Waitlist Available
Led By Robert. Bass, MD
Research Sponsored by Auzone Biological Technology Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Combined injectable contraceptives
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours each postdose
Awards & highlights

Study Summary

This trial assesses the bioequivalence, safety, and tolerability of 3 treatments for healthy adults. 30 people will receive each treatment in a randomized sequence.

Who is the study for?
Healthy men and women aged 20-45, non-smokers or light smokers (≤5 cigarettes per day), with a BMI of 19 to 30 kg/m2. Women must be postmenopausal, surgically sterile, or using effective contraception. Participants should not have allergies to study drugs, no recent infections or vaccinations, no drug/alcohol abuse history, and must not be on certain medications.Check my eligibility
What is being tested?
The trial is testing the bioequivalence of TTYP01 tablets compared to Radicava injection and Radicava ORS in healthy adults under fasting conditions. It's an open-label study where each participant will receive all three treatments in different periods following a random sequence.See study design
What are the potential side effects?
While specific side effects are not listed for this Phase 1 trial focused on healthy subjects, potential risks may include reactions at the tablet ingestion site or injection-related issues such as pain or inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am using injectable birth control.
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I am postmenopausal, confirmed by a blood test.
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I am surgically sterile, as confirmed by medical documents.
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I am only using hormonal oral contraceptives.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 hours each postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 hours each postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK Parameters - Maximum observed concentration （Cmax） of unchanged edaravone after TTYP01, Radicava and Radicava ORS administration
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
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
Secondary outcome measures
Incidence and Number of Participants with Adverse events and adverse drug reactions
PK Parameters - Apparent terminal elimination half-life （T1/2el）of unchanged edaravone, sulfate, and glucuronide metabolites after TTYP01, Radicava, and Radicava ORS administration
PK Parameters - Apparent terminal elimination rate constant （Kel）of unchanged edaravone, sulfate and glucuronide metabolites after TTYP01, Radicava and Radicava ORS administration
+9 more

Trial Design

3Treatment groups
Active Control
Group I: TTYP01Active Control1 Intervention
Healthy subjects were administered 1 single oral dose of 90 mg TTYP01 (3 tablets of the test drugs, test formulation T)
Group II: RadicavaActive Control1 Intervention
Healthy subjects were administered 1 injection of 60 mg Radicava (reference drug R1, intravenous infusion of 60 mg administered over 60 minutes)
Group III: Radicava ORSActive Control1 Intervention
Healthy subjects were administered 1 single oral dose of 105 mg/5 mL Radicava ORS (reference drug R2)

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Auzone Biological Technology Pty LtdLead Sponsor
1 Previous Clinical Trials
72 Total Patients Enrolled
1 Trials studying Healthy Adult Subjects
72 Patients Enrolled for Healthy Adult Subjects
Robert. Bass, MDPrincipal InvestigatorICON plc

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this trial open to me?

"For inclusion in this clinical trial, applicants must be of adult age (20-45) and in optimal health. At present, approximately 30 participants are sought out for the study."

Answered by AI

Does this experiment encompass individuals aged fifty or above?

"As per the eligibility requirements of this trial, no participant can be younger than 20 years old or older than 45."

Answered by AI

How many individuals are presently receiving treatment in this trial?

"Affirmative. Clinicaltrials.gov confirms that this trial is still seeking candidates, which was first advertised on September 27th 2023 and most recently updated on October 24th 2023. A total of 30 patients are sought at a single medical facility."

Answered by AI

Has the FDA cleared TTYP01 for general use?

"Considering the limited clinical information available, TTYP01 has been assigned a safety rating of 1. This is because it's only in Phase 1 testing and there is yet to be sufficient evidence supporting efficacy or safety."

Answered by AI

Are there still spots available for participants in this experiment?

"Affirmative. Patient recruitment is currently underway for this research, which was first listed on September 27th 2023 and most recently updated a month later. The study requires 30 volunteers from one medical site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects
2023. "Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06107205.
~19 spots leftby Apr 2025
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