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Lucid-21-302

Phase 1

Healthy Participants | Small molecule | Other |Quantum Biopharma Ltd.|Last Updated: Aug 29, 2023

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
NCT05821387Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy VolunteersPHASE1 COMPLETED 40Mar 22, 2023Jul 29, 2023Aug 29, 20231 Canada
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Study Endpoints
Primary Endpoints
Single Dose Safety Outcome Measures
Up to 12 days

Incidence and severity of adverse events (AEs), laboratory, ECG, physical exam, neurological exam and vital sign changes

AUC from time zero to the last non-zero concentration after single dose
Pre-dose to 48 hours post-dose

PK characteristics after single dose

Cmax after single dose
Pre-dose to 48 hours post-dose

PK characteristics after single dose

Tmax after single dose
Pre-dose to 48 hours post-dose

PK characteristics after single dose

AUC0-inf after single dose
Pre-dose to 48 hours post-dose

PK characteristics after single dose

t1/2 after single dose
Pre-dose to 48 hours post-dose

PK characteristics after single dose

Kel after single dose
Pre-dose to 48 hours post-dose

PK characteristics after single dose

CL/F after single dose
Pre-dose to 48 hours post-dose

PK characteristics after single dose

Vd/F after single dose
Pre-dose to 48 hours post-dose

PK characteristics after single dose

Effect of Food on the single dose AUC from time zero to the last non-zero concentration
Pre-dose to 48 hours post-dose

Effect of food on the single dose PK

Effect of Food on the single dose Cmax
Pre-dose to 48 hours post-dose

Effect of food on the single dose PK

Effect of Food on the single dose Tmax
Pre-dose to 48 hours post-dose

Effect of food on the single dose PK

Effect of Food on the single dose AUC0-inf
Pre-dose to 48 hours post-dose

Effect of food on the single dose PK

Effect of Food on the single dose t1/2
Pre-dose to 48 hours post-dose

Effect of food on the single dose PK

Effect of Food on the single dose Kel
Pre-dose to 48 hours post-dose

Effect of food on the single dose PK

Effect of Food on the single dose CL/F
Pre-dose to 48 hours post-dose

Effect of food on the single dose PK

Effect of Food on the single dose Vd/F
Pre-dose to 48 hours post-dose

Effect of food on the single dose PK

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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Lucid-21-302EXPERIMENTALSingle-ascending dose cohorts
PlaceboPLACEBO_COMPARATORSingle-ascending dose cohorts
Interventions
NameTypeDescription
Lucid-21-302DRUGA small molecule inhibitor of hypercitrullination
PlaceboDRUGProduct containing excipients with no active ingredients
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male and female volunteers, 18 - 60 years of age, inclusive at the time of informed consent. 2. Body mass index (BMI) that is within 18.5 - 30.0 kg/m2, inclusive, and minimum weight of 50 kg. 3. Healthy, according to the medical history, ECG, vital signs, laboratory r...

Countries:Canada
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