Healthy ParticipantsPhase 1NCT05821387
Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy Volunteers
A Phase 1 study testing Lucid-21-302 in people with Healthy Participants, run by Quantum Biopharma at 1 site in Canada.
Trial summary
This study aims to determine the safety, tolerability, and pharmacokinetics of single doses of Lucid-21-302 in healthy adult volunteers. This study will also investigate the effects of food in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Lucid-21-302
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 22 Mar 2023to 29 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers, 18 - 60 years of age, inclusive at the time of informed consent.
- Body mass index (BMI) that is within 18.5 - 30.0 kg/m2, inclusive, and minimum weight of 50 kg.
- Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
- QTcF interval ≤ 440 msec for males and ≤ 460 msec for females, unless deemed otherwise by the PI/Sub-Investigator.
- Systolic blood pressure between 95 - 140 mmHg, inclusive, and diastolic blood pressure between 55 - 90 mmHg, inclusive, and heart rate between 50 - 100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
- Clinical laboratory values within the laboratory test ranges and/or values in the clinical site's SOPs that are classified as "Not Clinically Significant."
Show all 23Show fewer
- Non-smoker and non-nicotine user, for at least six months prior to study drug administration.
- Ability to comprehend and be informed of the nature of the study, as assessed by PI. Capable of giving written informed consent prior to any study related procedure. Must be able to communicate effectively with clinic staff.
- Ability to speak, read, and understand English sufficiently to allow completion of all study assessments.
- Ability to consume standard meals and the ability to fast for at least 14 hours for the SAD study and at least ten hours for the MAD study.
- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
- Agree not to have a tattoo or body piercing until the end of the study.
- Agree not to receive the COVID-19 vaccination or other vaccination from seven days prior to the study drug dose until seven days after study drug administration in the study.
- Agree not to drive or operate heavy machinery if feeling dizzy, drowsy, or otherwise mentally impaired following study drug administration until full mental alertness is regained.
- Female participants must be non-pregnant and non-lactating and fulfill at least one of the following:
- Be surgically sterile for a minimum of six months (achieved through hysterectomy, oophorectomy, or bilateral salpingectomy; note that tubal ligation is not considered a method of permanent sterilization).
- Post-menopausal for a minimum of one year (postmenopausal is confirmed by serum FSH values collected at screening).
- Agree to avoid pregnancy and use an acceptable effective method of contraception with male sexual partners from at least 30 days prior to the study until at least 30 days after the study has ended (last study procedure).
- Acceptable effective methods of contraception include using a male condom in conjunction with non-hormonal contraceptives, such as a non-hormonal intrauterine device; or a double-barrier method (e.g., male condom with diaphragm and spermicide used simultaneously, male condom with cervical cap and spermicide used simultaneously). Abstinence as a method of contraception is acceptable if it is in line with the preferred and usual lifestyle of the study participant.
- Males who are able to father children must agree to use an acceptable effective method of contraception with female sexual partners of childbearing potential and not donate sperm during the study and for at least 90 days after the last dose of the study drug (Lucid-21-302 or placebo).
- Acceptable effective methods of contraception include using a male condom with a female sexual partner of childbearing potential who is using oral contraceptives, hormonal patch, implant or injection, intrauterine device or system; or a double-barrier method (e.g., male condom with diaphragm and spermicide used simultaneously, male condom with cervical cap and spermicide used simultaneously). Abstinence as a method of contraception is acceptable if it is in line with the preferred and usual lifestyle of the study participant.
- If a participant's partner becomes pregnant during his participation in the study and for 90 days after he has completed his last study drug administration, he must inform site staff immediately.
- Deemed suitable for the study by the PI/Sub-Investigator and/or clinical staff.
Who cannot join
- Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
- o AST, ALP, ALT, bilirubin, and/or GGT levels that are outside of normal laboratory ranges
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within seven days prior to first study drug administration, as determined by the PI/Sub-Investigator.
- History of seizures, family history of seizures, history of head trauma, history of neurosurgery, or first-degree relative with idiopathic generalized epilepsy or other congenital epilepsies.
- Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
- Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
Show all 28Show fewer
- A positive test result for human immunodeficiency virus (HIV), chronic Hepatitis B surface antigen, or Hepatitis C.
- A positive test result for drugs with abuse potential (cannabis, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), breath alcohol test or urine cotinine test.
- Positive pregnancy test for female participants.
- Known history or presence of:
- Food allergies;
- Presence of any dietary restrictions unless deemed by the PI/Sub-I as "Not Clinically Significant;"
- Severe allergic reactions (e.g., anaphylactic reactions, angioedema).
- Intolerance to and/or difficulty with blood sampling through venipuncture.
- Individuals who have donated, in the days prior to first study drug administration:
- 50-499 mL of blood in the previous 30 days;
- 500 mL or more in the previous 56 days.
- Donation of plasma by plasmapheresis within 7 days prior to study drug administration.
- Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to study drug administration.
- Use of any enzyme-modifying drugs and/or other products, including strong inhibitors of cytochrome P450 (CYP) enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (e.g., barbiturates, carbamazepine, glucocorticoids, phenytoin, St. John´s Wort, and rifampicin) in the previous 30 days before study drug administration.
- Use of any prescription medication within 14 days prior to study drug administration.
- Use of any over-the-counter medications (including oral multivitamins, herbal and/or dietary supplements) within 14 days prior to study drug administration.
- Consumption of food or beverages containing grapefruit and/or pomelo within 10 days prior to study drug administration.
- Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hr before dosing (includes coffee and tea).
- Individuals having undergone any major surgery within six months prior to the start of the study, unless deemed otherwise by PI/Sub-Investigator.
- Have any other conditions that, in the opinion of the Investigator or Sponsor, would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study.
- Difficulty with swallowing tablets or capsules.
- Have had a tattoo or body piercing within 30 days prior to study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Lucid-21-302 in Healthy Volunteers Under Fed and Fasted Conditions
This study aims to determine the safety, tolerability, and pharmacokinetics of single doses of Lucid-21-302 in healthy adult volunteers. This study will also investigate the effects of food in healthy volunteers.
- Conditions
- Healthy Participants
- Being tested
- Lucid-21-302, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucid-21-302Drug
A small molecule inhibitor of hypercitrullination
PlaceboDrug
Product containing excipients with no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Lucid-21-302 | Experimental | Single-ascending dose cohorts Receives: Drug: Lucid-21-302 |
| Placebo | Placebo comparator | Single-ascending dose cohorts Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Dose Safety Outcome Measures
Incidence and severity of adverse events (AEs), laboratory, ECG, physical exam, neurological exam and vital sign changes
Measured: Up to 12 days
AUC from time zero to the last non-zero concentration after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours post-dose
Cmax after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours post-dose
Tmax after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours post-dose
AUC0-inf after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours post-dose
t1/2 after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours post-dose
Kel after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours post-dose
CL/F after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours post-dose
Vd/F after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours post-dose
Effect of Food on the single dose AUC from time zero to the last non-zero concentration
Effect of food on the single dose PK
Measured: Pre-dose to 48 hours post-dose
Effect of Food on the single dose Cmax
Effect of food on the single dose PK
Measured: Pre-dose to 48 hours post-dose
Effect of Food on the single dose Tmax
Effect of food on the single dose PK
Measured: Pre-dose to 48 hours post-dose
Effect of Food on the single dose AUC0-inf
Effect of food on the single dose PK
Measured: Pre-dose to 48 hours post-dose
Effect of Food on the single dose t1/2
Effect of food on the single dose PK
Measured: Pre-dose to 48 hours post-dose
Effect of Food on the single dose Kel
Effect of food on the single dose PK
Measured: Pre-dose to 48 hours post-dose
Effect of Food on the single dose CL/F
Effect of food on the single dose PK
Measured: Pre-dose to 48 hours post-dose
Effect of Food on the single dose Vd/F
Effect of food on the single dose PK
Measured: Pre-dose to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start22 Mar 2023
- Primary completion29 Jul 2023
- Study completion29 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 5 SAD Cohorts. Each SAD cohort will enroll 8 participants randomized 6 active:2 placebo to receive single doses of Lucid-21-302. For SAD cohort with food effect, all 8 participants will receive Lucid-21-302.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lucid Psycheceuticals Inc. (sub of FSD Pharma, Inc.)
- Responsible party
- Sponsor
- Investigators
- Isabella Szeto, MD, Principal investigator, Biopharma Services Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821387
- Sponsor's protocol ID
- Lucid-21-302-001
- Other IDs
- 2786
- Status last verified
- Aug 2023
- First submitted
- 21 Mar 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tejeda EJC, Bello AM, Wasilewski E, Koebel A, Dunn S, Kotra LP. Noncovalent Protein Arginine Deiminase (PAD) Inhibitors Are Efficacious in Animal Models of Multiple Sclerosis. J Med Chem. 2017 Nov 9;60(21):8876-8887. doi: 10.1021/acs.jmedchem.7b01102. Epub 2017 Oct 30.
PubMed 29045782Caprariello AV, Rogers JA, Morgan ML, Hoghooghi V, Plemel JR, Koebel A, Tsutsui S, Dunn JF, Kotra LP, Ousman SS, Wee Yong V, Stys PK. Biochemically altered myelin triggers autoimmune demyelination. Proc Natl Acad Sci U S A. 2018 May 22;115(21):5528-5533. doi: 10.1073/pnas.1721115115. Epub 2018 May 4.
PubMed 29728463
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Lucid-21-302 in Healthy Volunteers Under Fed and Fasted Conditions
- ClinicalTrials.gov ID
- NCT05821387
- Acronym / sponsor ID
- Lucid-21-302-001
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Quantum BiopharmaIndustry (pharma, biotech, devices)
- Collaborators
- Lucid Psycheceuticals Inc. (sub of FSD Pharma, Inc.)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 29 Jul 2023 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the safety, tolerability, and pharmacokinetics of single doses of Lucid-21-302 in healthy adult volunteers. This study will also investigate the effects of food in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 5 SAD Cohorts. Each SAD cohort will enroll 8 participants randomized 6 active:2 placebo to receive single doses of Lucid-21-302. For SAD cohort with food effect, all 8 participants will receive Lucid-21-302.
| Arm | Type | Receives |
|---|---|---|
| Lucid-21-302 | Experimental | Drug: Lucid-21-302Single-ascending dose cohorts |
| Placebo | Placebo comparator | Drug: PlaceboSingle-ascending dose cohorts |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Healthy male and female volunteers, 18 - 60 years of age, inclusive at the time of informed consent.
- Body mass index (BMI) that is within 18.5 - 30.0 kg/m2, inclusive, and minimum weight of 50 kg.
- Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
- QTcF interval ≤ 440 msec for males and ≤ 460 msec for females, unless deemed otherwise by the PI/Sub-Investigator.
- Systolic blood pressure between 95 - 140 mmHg, inclusive, and diastolic blood pressure between 55 - 90 mmHg, inclusive, and heart rate between 50 - 100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
Key exclusion criteria (28 listed)
- Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
- o AST, ALP, ALT, bilirubin, and/or GGT levels that are outside of normal laboratory ranges
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within seven days prior to first study drug administration, as determined by the PI/Sub-Investigator.
- History of seizures, family history of seizures, history of head trauma, history of neurosurgery, or first-degree relative with idiopathic generalized epilepsy or other congenital epilepsies.
- Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lucid-21-302A small molecule inhibitor of hypercitrullination | Drug | Lucid-21-302 |
| PlaceboProduct containing excipients with no active ingredients | Drug | Placebo |
Primary outcome
Single Dose Safety Outcome Measures
Time frame: 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
Time frame: Pre-dose to 48 hours post-dose
PK characteristics after single dose
Cmax after single dose
Time frame: Pre-dose to 48 hours post-dose
PK characteristics after single dose
Tmax after single dose
Time frame: Pre-dose to 48 hours post-dose
PK characteristics after single dose
AUC0-inf after single dose
Time frame: Pre-dose to 48 hours post-dose
PK characteristics after single dose
t1/2 after single dose
Time frame: Pre-dose to 48 hours post-dose
PK characteristics after single dose
Kel after single dose
Time frame: Pre-dose to 48 hours post-dose
PK characteristics after single dose
CL/F after single dose
Time frame: Pre-dose to 48 hours post-dose
PK characteristics after single dose
Vd/F after single dose
Time frame: 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
Time frame: Pre-dose to 48 hours post-dose
Effect of food on the single dose PK
Effect of Food on the single dose Cmax
Time frame: Pre-dose to 48 hours post-dose
Effect of food on the single dose PK
Effect of Food on the single dose Tmax
Time frame: Pre-dose to 48 hours post-dose
Effect of food on the single dose PK
Effect of Food on the single dose AUC0-inf
Time frame: Pre-dose to 48 hours post-dose
Effect of food on the single dose PK
Effect of Food on the single dose t1/2
Time frame: Pre-dose to 48 hours post-dose
Effect of food on the single dose PK
Effect of Food on the single dose Kel
Time frame: Pre-dose to 48 hours post-dose
Effect of food on the single dose PK
Effect of Food on the single dose CL/F
Time frame: Pre-dose to 48 hours post-dose
Effect of food on the single dose PK
Effect of Food on the single dose Vd/F
Time frame: Pre-dose to 48 hours post-dose
Effect of food on the single dose PK
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Background: PubMed 29045782Tejeda EJC, Bello AM, Wasilewski E, Koebel A, Dunn S, Kotra LP. Noncovalent Protein Arginine Deiminase (PAD) Inhibitors Are Efficacious in Animal Models of Multiple Sclerosis. J Med Chem. 2017 Nov 9;60(21):8876-8887. doi: 10.1021/acs.jmedchem.7b01102. Epub 2017 Oct 30.
- Background: PubMed 29728463Caprariello AV, Rogers JA, Morgan ML, Hoghooghi V, Plemel JR, Koebel A, Tsutsui S, Dunn JF, Kotra LP, Ousman SS, Wee Yong V, Stys PK. Biochemically altered myelin triggers autoimmune demyelination. Proc Natl Acad Sci U S A. 2018 May 22;115(21):5528-5533. doi: 10.1073/pnas.1721115115. Epub 2018 May 4.
- Website for FSD Pharma Inc.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabella Szeto, MD principal investigator
Biopharma Services Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lucid-21-302 in people with Healthy Participants, run by Quantum Biopharma at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Dose Safety Outcome Measures (time frame: Up to 12 days). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05821387, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.