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
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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.
Tyra Biosciences, Inc is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Started Oct 2023 (actual). Primary completion is estimated for May 2025, 19 months after the start.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Dabogratinib
Tyra Biosciences, Inc