A Phase 1 interventional study of TYRA-300-B01 in Healthy, sponsored by Tyra Biosciences, Inc. Active, not recruiting at 1 site in Australia. Open to participants aged 26 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Tyra Biosciences, Inc · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the relative bioavailability of capsule and tablet formulations of TYRA-300-B01, and to evaluate the safety, tolerability, and food effect of TYRA-300-B01 tablets in healthy adult participants.
This is a Phase 1, multi-cohort trial studying TYRA-300-B01, a novel, potent fibroblast growth factor receptor (FGFR) 3-selective tyrosine kinase inhibitor, in healthy, adult participants. The purpose of this study is to evaluate the relative bioavailability of capsule and tablet formulations of TYRA-300-B01, and to evaluate the safety, tolerability, and food effect of TYRA-300-B01 tablets in healthy adult participants.
Exclusion Criteria:
TYRA-300-B01 single oral dose of tablet or capsule crossover followed by twice-daily tablet dosing
Drug: TYRA-300-B01
TYRA-300-B01 single oral dose of tablet in the fed and fasted state
Drug: TYRA-300-B01
TYRA-300-B01 single oral dose
Drug: TYRA-300-B01
TYRA-300-B01 multiple-dose mini-tablet formulation
Drug: TYRA-300-B01
TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3.
Pharmacokinetics single-dose Cmax
maximum plasma concentration (Cmax)
Time frame: Up to 48 hours post-dose
Pharmacokinetics multiple-dose Cmax
maximum steady-state plasma concentration (Cmax)
Time frame: Up to 24 hours post-dose
Pharmacokinetics multiple-dose Cmin
average steady-state trough plasma concentration (Cmin)
Time frame: Up to 24 hours post-dose
Pharmacokinetics single dose Tmax
time to reach maximum plasma concentration (Tmax)
Time frame: Up to 48 hours post-dose
Pharmacokinetics single and multiple dose AUC
area under the plasma concentration-time curve (AUC)
Time frame: Up to 48 hours post-dose
Pharmacokinetics single dose CL/F
apparent total clearance (CL/F)
Time frame: Up to 48 hours post-dose
Pharmacokinetics single dose Vz/F
apparent volume of distribution (Vz/F)
Time frame: Up to 48 hours post-dose
Pharmacokinetics single dose t1/2
half-life of TYRA-300
Time frame: Up to 48 hours post-dose
Pharmacokinetics multiple-dose RCmax
accumulation ratio for Cmax (RCmax)
Time frame: Up to 24 hours post-dose
Pharmacokinetics multiple-dose RAUC
accumulation ratio for AUC
Time frame: Up to 24 hours post-dose
Safety and tolerability
number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs) as a measure of safety and tolerability
Time frame: Initiation of study treatment up to 7-days post treatment
Safety and tolerability
Frequency in changes in laboratory parameters and physical signs of toxicity
Time frame: Initiation of study treatment up to 7-days post treatment
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Tyra Biosciences, Inc