Phase 1
Completed N=27
A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy Participants
Healthy Participants
Source: ClinicalTrials.gov NCT05138653 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Part A: Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 0; 0; 0; 1 Participants
Summary
This is a 2-part, double-blind, randomized, placebo-controlled, first-in-human trial evaluating a single ascending dose (4-way crossover, Part A) and multiple ascending doses (Part B) of CVL-354.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
0; 0; 0; 1; 0; 1 | — |
| PRIMARY Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Sign Measurements |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part A: Cohorts 1 and 2: Number of Participants With Changes in Suicidal Ideation or Suicidal Behavior Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part A: Cohort 3: Number of Participants With TEAEs |
0; 2 | — |
| PRIMARY Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in ECG Parameters |
0; 0 | — |
| PRIMARY Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in Vital Sign Measurements |
0; 0 | — |
| PRIMARY Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters |
0; 0 | — |
| PRIMARY Part A: Cohort 3: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations |
0; 0 | — |
| PRIMARY Part A: Cohort 3: Number of Participants With Changes in C-SSRS |
0; 0 | — |
| PRIMARY Part B: Number of Participants With TEAEs |
2; 0; 1; 2; 2; 3 | — |
| PRIMARY Part B: Number of Participants With Clinically Significant Changes in ECG Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part B: Number of Participants With Clinically Significant Changes in Vital Sign Measurements |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part B: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part B: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part B: Number of Participants With Changes in C-SSRS |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Women of nonchildbearing potential and men 18 to 55 years, inclusive.
- Healthy as determined by medical evaluation, including medical and psychiatric history, physical and neurological examinations, Electrocardiogram (ECG), vital sign measurements, and laboratory test results, as evaluated by the investigator.
- Body mass index of 18.5 to 30.0 Kilograms per square meter (kg/m^2), inclusive, and total body weight >50 Kilogram (kg) [110 Pound (lb)] at Screening.
- A male participant with a pregnant or a nonpregnant partner of childbearing potential must agree to use contraception during the trial and 14 days following the last dose of study drug.
- Capable of giving signed informed consent
- Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements.
Exclusion Criteria
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine, hematological, immunological, or neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
- Serious risk of suicide in the opinion of the Investigator
- History of substance or alcohol-use disorder (excluding nicotine or caffeine) within 12 months prior to signing the informed consent form (ICF).
- Any condition that could possibly affect drug absorption
- Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination or booster as follows:
- messenger ribonucleic acid (mRNA): within 14 days prior to dosing
- Non-mRNA: within 28 days prior to dosing In addition, participants who plan to receive SARS-CoV2 vaccination or booster while participating in the trial or for at least 14 days after the last dose of investigational medicinal product (IMP) will be excluded.
- Have recently been diagnosed with symptomatic corona virus disease-2019 (COVID-19) or test positive for COVID-19 within 30 days prior to signing the ICF.
- Use of prohibited medication prior to randomization or likely to require prohibited concomitant therapy (eg, prescription and over-the-counter medications, herbal medications, vitamins, and supplements) during the trial
- Either of the following:
- History of human immunodeficiency viruses (HIV), hepatitis B, or hepatitis C infection
- Positive result for HIV antibody, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody
- Positive drug screen (including nicotine) or a positive test for alcohol
- Abnormal clinical laboratory test results or vital measurements at Screening and Check-in
- Estimated glomerular filtration rate at Screening <90 millilitre/minute/1.73m^2 (mL/min/1.73 m^2), as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- Abnormal 12-lead ECG at Screening or initial Check-In (Day -1).
- Known allergy or hypersensitivity to the IMP, closely related compounds, or any of their specified ingredients.
- Current enrollment or past participation within 30 days or 5 half-lives (whichever is longer) prior to signing the ICF in any other clinical trial involving an IMP.
- Any other abnormal safety findings unless, based on the investigator's judgment, the findings are not medically significant and would not impact the safety of the participant or the interpretation of the trial results.
Data sourced from ClinicalTrials.gov (NCT05138653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.