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Lucid-21-302

Phase 1

Healthy Participants | Small molecule | Other |Quantum Biopharma Ltd.|Last Updated: Mar 5, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Lucid-21-302 · 2 trials · 2 indications

Phase 1 2
NCT06595706Evaluating the Safety and Pharmacokinetics of Multiple Ascending Doses of Lucid-21-302 in Healthy Adult ParticipantsHeathy Participants
COMPLETED16 Analytics
NCT05821387Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy VolunteersHealthy Participants
COMPLETED40 Analytics
PHASE1COMPLETED
Evaluating the Safety and Pharmacokinetics of Multiple Ascending Doses of Lucid-21-302 in Healthy Adult Participants
Heathy ParticipantsUnlock trial analytics
PHASE1COMPLETED
Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy Volunteers
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence, severity and relationship of Adverse Events (AEs)
Up to 15 days

Safety Outcome Measure

Incidence of Serious AEs (SAEs) and suspected unexpected SAEs
Up to 15 days

Safety Outcome Measure

Number of discontinuations due to AEs
Up to 15 days

Safety Outcome Measure

Clinically significant changes from baseline in complete blood count
Up to 15 days

Safety blood test measured by a laboratory using a reference range

Clinically significant changes from baseline in blood coagulation
Up to 15 days

Safety blood test measured by a laboratory using a reference range

Clinically significant changes from baseline in blood biochemistry
Up to 15 days

Safety blood test measured by a laboratory using a reference range

Clinically significant changes from baseline in urinalysis
Up to 15 days

Safety urine test measured by a laboratory using a reference range

Clinically significant changes from baseline in physical exam
Up to 15 days

Safety Outcome Measure, clinical exam performed by a licensed physician

Clinically significant changes from baseline in systolic blood pressure
Up to 15 days

Safety Outcome Measure, measured in mmHg

Clinically significant changes from baseline in diastolic blood pressure
Up to 15 days

Safety Outcome Measure, measured in mmHg

Clinically significant changes from baseline in heart rate
Up to 15 days

Safety Outcome Measure, measured in beats per minute

Clinically significant changes from baseline in respiratory rate
Up to 15 days

Safety Outcome Measure, measured in breaths per minute

Clinically significant changes from baseline in tympanic temperature
Up to 15 days

Safety Outcome Measure, measured in degrees Celcius

Clinically significant changes from baseline in 12-lead electrocardiogram (ECG)
Up to 15 days

Safety Outcome Measure, measured using a standard ECG machine

Clinically significant changes from baseline in patient health questionnaire (PHQ-9)
Up to 15 days

Safety Outcome Measure, PHQ-9 is a depression scale with scores ranging from 0 to 27 with higher scores indicating more depressive symptoms

Clinically significant changes from baseline in generalized anxiety disorder questionnaire (GAD7)
Up to 15 days

Safety Outcome Measure, GAD7 is an anxiety scale with scores ranging from 0 to 21 with higher scores indicating more anxiety symptoms

Clinically significant changes from baseline in Columbia suicide severity rating scale (C-SSRS)
Up to 15 days

Safety Outcome Measure, C-SSRS is an assessment tool that measures suicidal ideation and behavior. It consists of ten yes or no questions with yes answers indicating more thoughts of suicidality.

Clinically significant changes from baseline in neurological exam
Up to 15 days

Safety Outcome Measure, neurological exam performed by a licensed physician

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

Secondary Endpoints

AUC from time zero to 24 hours
Day1 (pre-dose to 24 hours post-dose)
AUC from time zero to the last non-zero concentration
Day1 (pre-dose to 24 hours post-dose)
Maximum concentration (Cmax)
Day1 (pre-dose to 24 hours post-dose)
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Study Design & Arms

AllocationNA
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lucid-21-302EXPERIMENTALMultiple ascending dose cohorts
PlaceboPLACEBO_COMPARATORMultiple ascending dose cohorts

Interventions

NameTypeDescription
Lucid-21-302DRUGCapsule containing a small molecule inhibitor of hypercitrullination
PlaceboDRUGCapsule containing only Silicified Microcrystalline Cellulose
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female, aged ≥18 and ≤60 years (inclusive), with BMI \>18.0 and \<32.0 kg/m2 and body weight ≥50.0 kg. Social smokers consuming less than 10 cigarettes per week, with a negative cotinine test at screening and Day -1 will be allowed. 2. Participant is judged by the Inv...

Countries:AustraliaCanada
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Frequently asked questions about Lucid-21-302

What is Lucid-21-302 used for?

Lucid-21-302 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with trials evaluating its safety, tolerability, and pharmacokinetics. It has not been approved for any indication and remains under investigation.

Who makes Lucid-21-302?

Lucid-21-302 is being developed by Quantum Biopharma Ltd., a company listed on the stock exchange under the ticker QNTM. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.

What phase is Lucid-21-302 in?

Lucid-21-302 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in Canada and one in Australia, both involving healthy adult participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Lucid-21-302 in?

Lucid-21-302 has two completed Phase 1 trials. NCT05821387 evaluated safety, tolerability, pharmacokinetics, and food effects in 40 healthy volunteers in Canada. NCT06595706 evaluated multiple ascending doses in 16 healthy participants in Australia. Both were randomized, double-blind, and placebo-controlled.

Is Lucid-21-302 the same as any other drug?

No alternative names for Lucid-21-302 have been reported. The drug is identified solely by its code name Lucid-21-302 in clinical trial registries and is being developed by Quantum Biopharma Ltd. under that designation.