Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy Volunteers

NCT05821387 | Completed Phase 1 DMC

• 2 other identifiers: Lucid-21-302-0012786
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (17)

• Single Dose Safety Outcome Measures

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

  Up to 12 days

• AUC from time zero to the last non-zero concentration after single dose

  PK characteristics after single dose

  Pre-dose to 48 hours post-dose

• Cmax after single dose

  PK characteristics after single dose

  Pre-dose to 48 hours post-dose

• Tmax after single dose

  PK characteristics after single dose

  Pre-dose to 48 hours post-dose

• AUC0-inf after single dose

  PK characteristics after single dose

  Pre-dose to 48 hours post-dose

• t1/2 after single dose

  PK characteristics after single dose

  Pre-dose to 48 hours post-dose

• Kel after single dose

  PK characteristics after single dose

  Pre-dose to 48 hours post-dose

• CL/F after single dose

  PK characteristics after single dose

  Pre-dose to 48 hours post-dose

• Vd/F after single dose

  PK characteristics after single dose

  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

  Pre-dose to 48 hours post-dose

• Effect of Food on the single dose Cmax

  Effect of food on the single dose PK

  Pre-dose to 48 hours post-dose

• Effect of Food on the single dose Tmax

  Effect of food on the single dose PK

  Pre-dose to 48 hours post-dose

• Effect of Food on the single dose AUC0-inf

  Effect of food on the single dose PK

  Pre-dose to 48 hours post-dose

• Effect of Food on the single dose t1/2

  Effect of food on the single dose PK

  Pre-dose to 48 hours post-dose

• Effect of Food on the single dose Kel

  Effect of food on the single dose PK

  Pre-dose to 48 hours post-dose

• Effect of Food on the single dose CL/F

  Effect of food on the single dose PK

  Pre-dose to 48 hours post-dose

• Effect of Food on the single dose Vd/F

  Effect of food on the single dose PK

  Pre-dose to 48 hours post-dose

Study Arms (2)

Lucid-21-302

EXPERIMENTAL

Single-ascending dose cohorts

Drug: Lucid-21-302

Placebo

PLACEBO COMPARATOR

Single-ascending dose cohorts

Drug: Placebo

Interventions

Lucid-21-302 DRUG

A small molecule inhibitor of hypercitrullination

Lucid-21-302

Placebo DRUG

Product containing excipients with no active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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."
• 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:

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Quantum Biopharma: lead
• Lucid Psycheceuticals Inc. (sub of FSD Pharma, Inc.): collaborator

Study Sites (1)

Biopharma Services Incorporated

Toronto, Ontario, M9L 3A2, Canada

Location

Related Publications (2)

• 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.

  PMID: 29045782 BACKGROUND

• Caprariello 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.

  PMID: 29728463 BACKGROUND

Related Links

• Website for FSD Pharma Inc.

Study Officials

• Isabella Szeto, MD

  Biopharma Services Incorporated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 20, 2023
• Study Start: March 22, 2023
• Primary Completion: July 29, 2023
• Study Completion: July 29, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)