Evaluating the Safety and Pharmacokinetics of Multiple Ascending Doses of Lucid-21-302 in Healthy Adult Participants

NCT06595706 | Completed Phase 1 DMC

• 1 other identifier: Lucid-21-302-002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the safety and pharmacokinetics of multiple ascending doses of Lucid-21-302 in healthy adult participants.

Conditions

Heathy Participants

Outcome Measures

Primary Outcomes (18)

• Incidence, severity and relationship of Adverse Events (AEs)

  Safety Outcome Measure

  Up to 15 days

• Incidence of Serious AEs (SAEs) and suspected unexpected SAEs

  Safety Outcome Measure

  Up to 15 days

• Number of discontinuations due to AEs

  Safety Outcome Measure

  Up to 15 days

• Clinically significant changes from baseline in complete blood count

  Safety blood test measured by a laboratory using a reference range

  Up to 15 days

• Clinically significant changes from baseline in blood coagulation

  Safety blood test measured by a laboratory using a reference range

  Up to 15 days

• Clinically significant changes from baseline in blood biochemistry

  Safety blood test measured by a laboratory using a reference range

  Up to 15 days

• Clinically significant changes from baseline in urinalysis

  Safety urine test measured by a laboratory using a reference range

  Up to 15 days

• Clinically significant changes from baseline in physical exam

  Safety Outcome Measure, clinical exam performed by a licensed physician

  Up to 15 days

• Clinically significant changes from baseline in systolic blood pressure

  Safety Outcome Measure, measured in mmHg

  Up to 15 days

• Clinically significant changes from baseline in diastolic blood pressure

  Safety Outcome Measure, measured in mmHg

  Up to 15 days

• Clinically significant changes from baseline in heart rate

  Safety Outcome Measure, measured in beats per minute

  Up to 15 days

• Clinically significant changes from baseline in respiratory rate

  Safety Outcome Measure, measured in breaths per minute

  Up to 15 days

• Clinically significant changes from baseline in tympanic temperature

  Safety Outcome Measure, measured in degrees Celcius

  Up to 15 days

• Clinically significant changes from baseline in 12-lead electrocardiogram (ECG)

  Safety Outcome Measure, measured using a standard ECG machine

  Up to 15 days

• Clinically significant changes from baseline in patient health questionnaire (PHQ-9)

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

  Up to 15 days

• Clinically significant changes from baseline in generalized anxiety disorder questionnaire (GAD7)

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

  Up to 15 days

• Clinically significant changes from baseline in Columbia suicide severity rating scale (C-SSRS)

  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.

  Up to 15 days

• Clinically significant changes from baseline in neurological exam

  Safety Outcome Measure, neurological exam performed by a licensed physician

  Up to 15 days

Secondary Outcomes (24)

• 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)

• Time to maximum concentration (Tmax)

  Day1 (pre-dose to 24 hours post-dose)

• AUC from time zero to the end of the dosing period

  Day 4 (pre-dose to 24 hours post-dose)

Study Arms (2)

Lucid-21-302

EXPERIMENTAL

Multiple ascending dose cohorts

Drug: Lucid-21-302

Placebo

PLACEBO COMPARATOR

Multiple ascending dose cohorts

Drug: Placebo

Interventions

Lucid-21-302 DRUG

Capsule containing a small molecule inhibitor of hypercitrullination

Lucid-21-302

Placebo DRUG

Capsule containing only Silicified Microcrystalline Cellulose

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Participant is judged by the Investigator to be in generally good health on the basis of medical history, physical examination, or clinical laboratory results during the screening.
• Pulse between 45 and 100 beats per minute (bpm) in supine position at screening (inclusive)
• Supine systolic BP between 90 and 160 mmHg, diastolic BP between 50 and 95 mmHg inclusive, at screening. For the purpose of qualifying any given participant for study participation, out-of-range vital signs may be repeated once.
• Ability to consume standard meals and the ability to fast for at least ten hours.
• 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.
• Must not be pregnant, breastfeeding (non-lactating), or planning pregnancy.
• Female participants must have negative serum hCG pregnancy test at screening and negative urine test a check-in.
• Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomised at least 6 months prior to the first study drug administration) must be willing to use one of the following acceptable contraceptive methods throughout the study and for at least 1 month after the last study drug administration:
• a. Simultaneous use of intrauterine contraceptive device with or without hormone release system placed at least 4 weeks prior to the first study drug administration; and a condom for the male partner. Oral contraceptives are not allowed.
• Females of non-childbearing potential must be:
• Post-menopausal (absence of menses for at least 12 months prior to the first study drug administration) with confirmation of the post menopausal status by documented FSH level ≥40 mIU/mL; or
• Surgically sterile (complete hysterectomy or bilateral oophorectomy at least 3 months prior to the first study drug administration).
• Female participants must be willing not to donate ova for 90 days after the last dose

You may not qualify if:

• History of any clinically significant gastrointestinal, renal, hepatic (except cholecystectomy), neurologic, hematologic, endocrine, oncologic, pulmonary (except resolved childhood astma), immunologic, or cardiovascular disease or other condition which would jeopardize safety or impact validity of results (in the opinion the Investigator); history of common medical conditions such as depression (non-hospitalised, but potentially medicated in the past), migraine or Gilbert syndrome will not be allowed unless the exemption will be provided by the Investigator.
• Participant has any documented clinically significant infection, injury, or illness within 1 month prior to screening.
• Participant has any documented history of, or currently active, seizure disorder (any seizure including infantile seizures), or history of clinically significant head injury based on the opinion of the Investigator.
• Participants who have a history of surgery within 6 months prior to screening, or who have a plan of surgery during the study. Small surgeries such as dental operation, biopsies and non-invasive surgeries may be allowed at Investigator discretion.
• Liver function test results elevated more than 1.5-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total, conjugated and unconjugated), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants; Testing for any out-of-range values may be repeated once at the discretion of the Investigator.
• A calculated creatinine clearance of \< 60 mL/minute at Screening according to the equation using Cockcroft and Gault.
• Testing for any out-of-range laboratory tests values may be repeated once at the discretion of the Investigator.
• Participant has an active malignancy of any type or has been diagnosed with cancer within 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
• Any laboratory test results deemed clinically significant by the Investigator or positive test serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
• Testing for any out-of-range laboratory tests values may be repeated once at the discretion of the Investigator.
• History of inherent cardiac abnormalities based on the opinion of the Investigator.
• Clinically significant ECG abnormalities in supine position defined at the Investigator discretion (Fridericia's corrected QT interval \[QTcF\] \>440 ms for males and \>460 ms for females), PR \>210 ms, QRS interval \> 120 ms at screening.
• Testing for any out-of-range values may be repeated once at the discretion of the Investigator.
• Clinically significant bradycardia or tachycardia in supine position defined at the Investigator discretion as resting heart rate (HR) \<44 bmp or \> 101 bpm, respectively.
• Testing for any out-of-range values may be repeated once at the discretion of the Investigator.

Sponsors & Collaborators

• Huge Biopharma Australia Pty Ltd: lead

Study Sites (1)

Cmax Clinical Research

Adelaide, Maryland, 5000, Australia

Location

Study Design

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

Model Details: 2 MAD cohorts. Each MAD cohort will enroll 8 participants randomized 6 active:2 placebo to receive multiple doses of Lucid-21-302.

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 28, 2024
• Primary Completion: January 24, 2025
• Study Completion: January 24, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)