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TYRA-300-B01

Phase 1

Undisclosed | Small molecule | Other |Tyra Biosciences, Inc.|Trials Updated: Mar 26, 2025

TYRA-300-B01 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2023

TYRA-300-B01 target and mechanism

Molecular targetFGFR3
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

TYRA-300-B01 clinical trials

TYRA-300-B01 · 1 trial · 1 indication

Phase 1 1
NCT06006702A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult ParticipantsHealthy
ACTIVE NOT_RECRUITING60 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics single-dose Cmax
Up to 48 hours post-dose

maximum plasma concentration (Cmax)

Pharmacokinetics multiple-dose Cmax
Up to 24 hours post-dose

maximum steady-state plasma concentration (Cmax)

Pharmacokinetics multiple-dose Cmin
Up to 24 hours post-dose

average steady-state trough plasma concentration (Cmin)

Pharmacokinetics single dose Tmax
Up to 48 hours post-dose

time to reach maximum plasma concentration (Tmax)

Pharmacokinetics single and multiple dose AUC
Up to 48 hours post-dose

area under the plasma concentration-time curve (AUC)

Pharmacokinetics single dose CL/F
Up to 48 hours post-dose

apparent total clearance (CL/F)

Pharmacokinetics single dose Vz/F
Up to 48 hours post-dose

apparent volume of distribution (Vz/F)

Pharmacokinetics single dose t1/2
Up to 48 hours post-dose

half-life of TYRA-300

Pharmacokinetics multiple-dose RCmax
Up to 24 hours post-dose

accumulation ratio for Cmax (RCmax)

Pharmacokinetics multiple-dose RAUC
Up to 24 hours post-dose

accumulation ratio for AUC

Secondary Endpoints

Safety and tolerability
Initiation of study treatment up to 7-days post treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Bioavailability Tablet vs Capsule FormulationEXPERIMENTALTYRA-300-B01 single oral dose of tablet or capsule crossover followed by twice-daily tablet dosing
Food Effect Tablet FormulationEXPERIMENTALTYRA-300-B01 single oral dose of tablet in the fed and fasted state
Pharmacokinetic Tablet FormulationEXPERIMENTALTYRA-300-B01 single oral dose
Pharmacokinetic Mini-Tablet FormulationEXPERIMENTALTYRA-300-B01 multiple-dose mini-tablet formulation

Interventions

NameTypeDescription
TYRA-300-B01DRUGTYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3.
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Eligibility Criteria

Age Range26 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:Australia
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Frequently asked questions about TYRA-300-B01

What is TYRA-300-B01?

TYRA-300-B01 is an investigational small molecule developed by Tyra Biosciences, Inc. It is being studied in a Phase 1 clinical trial, and no approved indication has been disclosed. The compound is designed to target FGFR3.

What does TYRA-300-B01 target?

TYRA-300-B01 targets FGFR3, a fibroblast growth factor receptor. By interacting with FGFR3, the small molecule is intended to modulate signaling pathways associated with this receptor. The specific therapeutic applications are not yet publicly disclosed.

Who makes TYRA-300-B01?

TYRA-300-B01 is being developed by Tyra Biosciences, Inc., a biopharmaceutical company. The company's ticker symbol is TYRA. Tyra Biosciences is responsible for the research and clinical development of this investigational asset.

What phase is TYRA-300-B01 in?

TYRA-300-B01 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory authority. The ongoing Phase 1 trial is evaluating the drug in healthy adult participants.

What clinical trials is TYRA-300-B01 in?

TYRA-300-B01 is being evaluated in a Phase 1 trial, NCT06006702, titled A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants. The trial is active but not recruiting, with an estimated enrollment of 60 participants in Australia.