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PRV-002

Phase 1

Traumatic Brain Injury (TBI) | Small molecule | Other |Odyssey Therapeutics, Inc.|Last Updated: Nov 4, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05033444A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy VolunteersPHASE1 COMPLETED 40 — — Feb 9, 2022Sep 13, 2024Nov 4, 20241 Australia
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Study Endpoints
Primary Endpoints
Safety endpoint - Evaluation of the Incidence, severity, and relationship of AEs/SAEs (or ADEs/SADEs) (including withdrawals due to AEs (or ADEs)).
Baseline pre-intervention (Day -28 to Day -2 and Day -1); during intervention and immediately afterwards (Day 1); Day 2; and through Day 5.

AEs/SAEs (or ADEs/SADEs) to be recorded as written descriptions on case report forms

Safety endpoint - Change from baseline in physical examination findings (Full)
Baseline pre-intervention Day -28 to -2.

Full physical exam including general appearance, head, ears, eyes, nose and throat, neck (including thyroid and lymph nodes), respiratory system, cardiovascular system, gastrointestinal system, renal system, neurological condition, musculoskeletal system, skin and any other focused assessments suggested by the presence of specific symptoms and measured by written descriptions.

Safety endpoint - Change from baseline in physical examination findings (symptom directed)
Baseline pre-intervention Day -1 and and Day 1; Day 2

Symptom-directed physical examination (focused assessments suggested by the presence of specific symptoms) will be performed if clinically indicated, as determined by the Investigator. The pre-dose physical examination assessment should be performed on the scheduled day, at any time prior to dosing. All other physical examinations will be performed within ± 1 hour of the nominated timepoint. Measured by written descriptions.

Safety endpoint - Change from baseline in vital signs (including changes from baseline in SpO2).
Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5

SpO2 measured as percent of oxygen (%)

Safety endpoint - Change from baseline in vital signs (including changes from baseline in blood pressure).
Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5

Blood pressure measured for systolic and diastolic pressure as mm of mercury.

Safety endpoint - Change from baseline in vital signs (including changes from baseline in heart rate).
Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5

Heart rate measured as beats per minute (BPM)

Safety endpoint - Change from baseline in vital signs (including changes from baseline in respiration rate).
Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5

Respiration rate measured as breaths per minute

Safety endpoint - Change from baseline in vital signs (including changes from baseline in body temperature).
Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5

Body temperature measured as degrees Celsius (C)

Safety endpoint - Changes from baseline in lung spirometry.
Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.25hr, 1hr, 10hr; Day 2 at 24 hr post intervention; Day 5

Lung spirometry measured as the ratio of forced expiratory value (FEV1)/ forced vital capacity (FVC) and reported as percentage (%)

Safety endpoint - Change from baseline in ECG parameters of heart rate
Baseline pre-intervention; during intervention and immediately afterwards (Day 1); Day 2; and through Day 5.

Heart ratel measured beats per minute (BPM)

Safety endpoint - Change from baseline in ECG parameters of PR interval, QRS interval, and QT interval
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 pre-intervention; Day 1 at 0.5hr, 2hr, 6hr; 12hr; Day 2 at 24 hr post intervention; Day 5

PR interval, QRS interval, and QT interval as measured in milliseconds (ms)

Safety endpoint - Change from baseline in hematocrit values
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5

Hematocrit measured as the percentage of red blood cells in whole blood (%)

Safety endpoint - Change from baseline in hemoglobin values
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5

Hemoglobin measured as the amount of hemoglobin in whole blood measured as grams per deciliter (g/dL)

Safety endpoint - Change from baseline in Red Blood Cell (RBC) indices
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5

RBC measured as the number of million RBCs per microliter (mcL) of blood

Safety endpoint - Change from baseline in Thrombocyte Count (Platelets); White Blood Cells (WBC); Basophils; Eosinophils; Lymphocytes; Monocytes; and Neutrophils.
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5

Platelets measured as the number of cells per microliter (mcL) of blood

Safety endpoint - Change from baseline in the blood hormone level of Dehydroepiandrosterone-sulfate (DHEAS)
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5

Dehydroepiandrosterone sulfate (DHEAS) measured as the number of micrograms per deciliter (µg/dL) of blood

Safety endpoint - Change from baseline in the blood hormone level of dihydrotestosterone (DHT)
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5

Dihydrotestosterone (DHT) measured as the number of nano moles per liter (nmol/L) of blood

Safety endpoint - Change from baseline in the blood hormone level of luteinizing hormone (LH)
Baseline pre-intervention Days -28 to -2

Luteinizing hormone (LH) measured as the number of International units per liter (IU/L)

Safety endpoint - Change from baseline in the blood hormone level of dehydroepiandrosterone sulfate (DHEAS)
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5

Dehydroepiandrosterone sulfate (DHEAS) measured as the number of micrograms per deciliter (mcg/dL)

Safety endpoint - Change from baseline in the blood hormone level of thyroid stimulating hormone (TSH)
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5

Thyroid stimulating hormone (TSH) measured as the number of milli-international units per liter (mIU/L)

Safety endpoint - For postmenopausal women only, change from baseline in the blood hormone level of follicle-stimulating hormone (FSH) and human chorionic gonadotropin (hGH)
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5

Follicle-stimulating hormone (FSH) and human chorionic gonadotropin (hGH) measured as the number of milli-international units per milliliter (mIU/mL)

Safety endpoint - Change from baseline in the blood hormone level of free thyroxine (FT4), testosterone, and dihydrotestosterone (DHT)
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5

Free thyroxine (FT4), testosterone, and dihydrotestosterone (DHT) measured as the number of nanograms per deciliter (ng/dL)

Safety endpoint - Change from baseline in the blood hormone level of progesterone
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5

Progesterone measured as the number of nanograms per miiliiliter (ng/mL)

Safety endpoint - Change from baseline in the blood hormone level of estradiol (E2) and free trilodothyronine (FT3)
Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5

Estradiol (E2) and free trilodothyronine (FT3) measured as the number of picograms per milliliter (pg/mL)

Safety endpoint Change in baseline in clotting factors Partial thromboplastin time (aPTT) and Prothrombin time (PT)
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5

Partial thromboplastin time (aPTT) and Prothrombin time (PT) measured as time to clot in seconds (sec)

Safety endpoint - Change from baseline in the clotting factor Fibrinogen
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5

Fibrinogen measured as the number of milligrams per deciliter (mg/dL)

Safety endpoint - Change from baseline in the clotting factor International Normalized Ratio (INR)
Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5

International Normalized Ratio (INR) measured as the ratio of patient PT/control PT

Safety endpoint - Change from baseline in urinalysis parameters bilirubin, blood, glucose, nitrites, protein, and urobilinogen
Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr

Bilirubin, blood, glucose, nitrites, protein, and urobilinogen measured as the number of milligrams per deciliter (mg/dL)

Safety endpoint - Change from baseline in urinalysis parameter ketones
Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr

Ketones measured as the number of millimoles per liter (mmol/L)

Safety endpoint - Change from baseline in urinalysis parameter leukocyte esterase
Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr

Leukocyte esterase measured as negative or positive; number of WBCs per high power field

Safety endpoint - Change from baseline in urinalysis parameter pH
Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr

pH measured as pH units

Safety endpoint - Change from baseline in urinalysis parameter specific gravity
Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr

Specific gravity measured as specific gravity units as a ratio of density of urine/density of water

Safety endpoint - Change from baseline in serum chemistry parameters globulin, protein, and albumin
Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.

Globulin, protein, and albumin measured as grams per deciliter (g/dL)

Safety endpoint - Change from baseline in serum chemistry parameter alkaline phosphatase
Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.

Alkaline phosphatase measured as International units per liter (IU/L)

Safety endpoint - Change from baseline in serum chemistry parameters bicarbonate, chloride, sodium, and magnesium
Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.

Bicarbonate, chloride, sodium, and magnesium measured as milliequivalents per liter (mEq/L)

Safety endpoint - Change from baseline in serum calcium, glucose, phosphate, creatinine, urea, uric acid, bilirubin (conjugated and unconjugated), high density lipoproteins, low density lipoproteins, total bilirubin, total cholesterol
Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.

Calcium, glucose, phosphate, creatinine, urea, uric acid, bilirubin (conjugated and unconjugated), high density lipoproteins, low density lipoproteins, total bilirubin, total cholesterol, triglycerides measured as milligrams per deciliter (mg/dL)

Safety endpoint - Change from baseline in serum chemistry parameters potassium
Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.

Potassium measured as millimoles per liter (mmol/L)

Safety endpoint - Change from baseline in serum chemistry parameters lipase, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyl transferase, alanine aminotransferase, and amylase
Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.

Lipase, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyl transferase, alanine aminotransferase, and amylase measured as Units per liter (U/L)

Safety endpoint - Change from baseline in virology parameters HIV-1/-2; HBsAg; HCV; SARS-COV-2
Baseline pre-intervention Day -28 to -2

HIV-1/-2; HBsAg; HCV; SARS-COV-2 test results measured as negative or positive

Safety endpoint - Change from baseline in drug screen findings for alcohol
Baseline pre-intervention Day -28 to -2; Day -1

Alcohol test results measured as percentage (%)

Safety endpoint - Change from baseline in urine drug screen findings for amphetamines, barbiturates, benzodiazepines, cocaine, cotinine, methamphetamines, opiates, phencyclidine, THC, and tricyclic antidepressants
Baseline pre-intervention Day -28 to -2; Day -1

Urine amphetamines, barbiturates, benzodiazepines, cocaine, cotinine, methamphetamines, opiates, phencyclidine, THC, and tricyclic antidepressants test results measured as nanograms per milliliter (ng/mL)

Safety endpoint - Change from baseline for pregnancy test for serum hCG and urine hCG
Serum pregnancy test Days -28 to -2 and on Day 5; Urine pregnancy test Day -1

Serum hCG and Urine hCG levels measured in milli-international units per liter (mIU/L)

Safety endpoint - Change from baseline for confirmation of postmenopausal status test for FSH
Baseline pre-intervention on Days -28 to -2

FSH levels measured in milli-international units per liter (mIU/L)

Secondary Endpoints
Plasma pharmacokinetics - Cmax
Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - Tmax
Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - area under the curve
Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRV-002EXPERIMENTALPRV-002 active formulation
Placebo comparatorPLACEBO_COMPARATORPlacebo used is hydroxypropyl beta cyclodextrin (HPβCD)
Interventions
NameTypeDescription
PRV-002DRUGSAD portion: Eligible participants will be randomized to receive a single ascending dose of PRV-002 on study Day 1. Dose escalation will be conducted in a total of 3 cohorts. Within each cohort, 6 participants will be randomized to receive a single dose of PRV-002. The starting dose, dose increments and dose range to be evaluated are based on available nonclinical data. PRV-002 dose levels in the range of 0.133 to 0.533 mg/kg (based on a 60kg participant) will be investigated. MAD portion: Eligible participants will be randomized to receive a multiple (one dose per day for 5 consecutive days). Dose escalation will be conducted in a total of 2 cohorts. Within each cohort, 6 participants will be randomized to receive of PRV-002. The starting dose, dose increments and dose range to be evaluated are based on available nonclinical data. PRV-002 dose levels in the range of 0.133 to 0.266 mg/kg (based on a 60kg participant) will be investigated.
PlaceboDRUGPlacebo used is hydroxypropyl beta cyclodextrin (HPβCD)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 2. Adult males and females, 18 to 55 years of age (inclusive) at...

Countries:Australia
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Competitive Landscape -Traumatic Brain Injury 15 trials
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Oragenics, Inc.OGEN1PHASE2Neurosteroid enantiomer
Novo Nordisk A/S Sponsored ADR Class BNVO1PHASE2Growth Hormone
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Summit Therapeutics IncSMMT1PHASE2Hyperbaric Oxygen Therapy
Cooper Companies, Inc.COO1NAUndisclosed
Grace Therapeutics, Inc.GRCE1 — Undisclosed
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