Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TYRA-300-B01 · 1 trial · 1 indication
maximum plasma concentration (Cmax)
maximum steady-state plasma concentration (Cmax)
average steady-state trough plasma concentration (Cmin)
time to reach maximum plasma concentration (Tmax)
area under the plasma concentration-time curve (AUC)
apparent total clearance (CL/F)
apparent volume of distribution (Vz/F)
half-life of TYRA-300
accumulation ratio for Cmax (RCmax)
accumulation ratio for AUC
| Arm | Type | Description |
|---|---|---|
| Bioavailability Tablet vs Capsule Formulation | EXPERIMENTAL | TYRA-300-B01 single oral dose of tablet or capsule crossover followed by twice-daily tablet dosing |
| Food Effect Tablet Formulation | EXPERIMENTAL | TYRA-300-B01 single oral dose of tablet in the fed and fasted state |
| Pharmacokinetic Tablet Formulation | EXPERIMENTAL | TYRA-300-B01 single oral dose |
| Pharmacokinetic Mini-Tablet Formulation | EXPERIMENTAL | TYRA-300-B01 multiple-dose mini-tablet formulation |
| Name | Type | Description |
|---|---|---|
| TYRA-300-B01 | DRUG | TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3. |
Inclusion Criteria: * Males or females of non-childbearing potential, between 18 and 55 years of age * In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory assessments * Body mass index (BMI) 18 ...
TYRA-300-B01 is an investigational small molecule being studied in healthy adult participants. It is currently in a Phase 1 clinical trial to evaluate the relative bioavailability and food effect of its capsule and tablet formulations. The drug is not approved for any medical condition and remains in clinical development.
TYRA-300-B01 is being developed by Tyra Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TYRA. The company is conducting a Phase 1 clinical trial to study the drug's formulations in healthy volunteers.
TYRA-300-B01 is in Phase 1 clinical development. The ongoing trial, NCT06006702, is a relative bioavailability and food effect study in healthy adult participants. The study is active but not recruiting, with an enrollment target of 60 participants.
TYRA-300-B01 is being studied in one active Phase 1 clinical trial, NCT06006702. This trial is titled 'A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants' and is being conducted in Australia.
TYRA-300-B01 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is studying the drug's capsule and tablet formulations in healthy volunteers to assess bioavailability and the effect of food on absorption.