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A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05238493
Recruitment Status : Recruiting
First Posted : February 14, 2022
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
Veloxis Pharmaceuticals

Brief Summary:
This study is primarily designed to assess the safety and tolerability of single doses of VEL-101 when administered subcutaneously (via injection into an area under the skin) or intravenously (via infusion into a vein). As each new group of participants is enrolled into the study, the dose administered to that group may be higher than a previous dose shown to be safe in other participants. The study is also designed to determine blood levels of VEL-101 and some substances produced by the immune system following VEL-101 administration. This information can provide insight into how quickly VEL-101 is eliminated from the body and some if its effects on the body.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: VEL-101 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Phase 1, Randomized, Double Blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101 Administered Intravenously or Subcutaneously in Healthy Subjects.
Actual Study Start Date : April 26, 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: Subcutaneous (SQ) Dose "A"
Single dose of VEL-101 by SQ injection
Drug: VEL-101
Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1

Experimental: Intravenous (IV) Dose "A"
Single dose of VEL-101 by IV infusion
Drug: VEL-101
Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1

Experimental: SQ Dose "B"
Single dose of VEL-101 by SQ injection
Drug: VEL-101
Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1

Experimental: SQ Dose "C"
Single dose of VEL-101 by SQ injection
Drug: VEL-101
Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1

Experimental: IV Dose "C"
Single dose of VEL-101 by IV infusion
Drug: VEL-101
Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1

Experimental: SQ Dose "D"
Single dose of VEL-101 by SQ injection
Drug: VEL-101
Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1

Experimental: SQ Dose "E"
Single dose of VEL-101 by SQ injection
Drug: VEL-101
Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1

Placebo Comparator: SQ or IV Placebo
Single dose of Placebo by SQ injection or IV infusion
Drug: Placebo
Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1




Primary Outcome Measures :
  1. Number and Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 through Day 50 ]
    Number and percentage of participants experiencing one or more adverse events which occurred or worsened in severity after initiation of investigational product (IP) dosing

  2. Number and Percentage of Participants with Serious TEAEs [ Time Frame: Day 1 through Day 50 ]
    Number and percentage of participants experiencing one or more serious TEAEs

  3. Number and Percentage of Participants with Grade 3 or Higher TEAEs [ Time Frame: Day 1 through Day 50 ]
    Number and percentage of participants experiencing one or more grade 3 TEAEs

  4. Number and Percentage of Participants with TEAEs Leading to Withdrawal from the Study [ Time Frame: Day 1 through Day 50 ]
    Number of participants experiencing one or more TEAEs directly resulting in withdrawal from the study

  5. Number and Percentage of Participants with TEAEs Leading to Death [ Time Frame: Day 1 through Day 50 ]
    Number and percentage of participants experiencing TEAEs that resulted in death


Secondary Outcome Measures :
  1. Number and Percentage of Participants with Abnormal Chemistry Panel Results [ Time Frame: Days -1, 2 (24 hours), 3, 5, 8, 15, 22, 29, 50 ]
    Descriptive statistics will summarize results (including change from baseline, as appropriate) of the following at each time point: sodium, potassium, chloride, calcium, bicarbonate, glucose, phosphorus, blood urea nitrogen, creatinine, creatine kinase, C-reactive protein, estimated glomerular filtration rate (eGFR), magnesium, amylase, uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), albumin, alkaline phosphatase, direct bilirubin, total bilirubin, indirect bilirubin, total protein, and lactate dehydrogenase

  2. Number and Percentage of Participants with Abnormal Hematology Panel Results [ Time Frame: Days -1, 2 (24 hours), 3, 5, 8, 15, 22, 29, 50 ]
    Descriptive statistics will summarize results (including change from baseline, as appropriate) of the following at each time point: hematocrit, hemoglobin, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), red blood cells (RBC), white blood cells (WBC) and differential, and platelets

  3. Number and Percentage of Participants with Abnormal Coagulation Panel Results [ Time Frame: Days -1, 2 (24 hours), 3, 5, 8, 15, 22, 29, 50 ]
    Descriptive statistics will summarize results (including change from baseline, as appropriate) of the following at each time point: prothrombin time (PT), international normalized ratio (INR), partial thromboplastin time (PTT), and fibrinogen

  4. Number and Percentage of Participants with Abnormal Urinalysis Results [ Time Frame: Days -1, 2 (24 hours), 3, 5, 8, 15, 22, 29, 50 ]
    Descriptive statistics will summarize results (including change from baseline, as appropriate) of the following at each time point: specific gravity, pH, leukocytes, erythrocytes, protein, glucose, nitrite, urobilinogen, bilirubin, ketones, and additional microscopic examination if blood or protein are abnormal

  5. Number and Percentage of Participants with Abnormal 12-lead Electrocardiogram (ECG) Results [ Time Frame: Days 1 (0, 1, 2, 3, 4, 5, 8, 12, 12, 16, and 20 hours), 2 (24, 30, 36, and 42 hours), 3, 4, 5, 8, 29, 50 ]
    Descriptive statistics will summarize results (including change from baseline, as appropriate) of the following at each time point: PR interval, QRS duration, QT interval, corrected QT interval (QTc), and corrected QT interval using Fridericia's formula (QTcF)

  6. Number and Percentage of Participants with Abnormal Vital Signs Results [ Time Frame: Days -1, 1 (0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 8, 12, 16, 20 hours), 2 (24, 30, 36, 42 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 ]
    Descriptive statistics will summarize results (including change from baseline, as appropriate) of the following at each time point: heart rate (HR), respiratory rate (RR), blood pressure (BP), temperature, and oxygen saturation

  7. CD28 Receptor Occupancy [ Time Frame: Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 15, 22, 29, 50 ]
    Proportion of target receptors occupied by VEL-101

  8. Number and Percentage of Participants with Anti-drug Antibody (ADA) Formation [ Time Frame: Days 1 (0 hour), 15, 29, 50 ]
    Presence of detectable anti-VEL-101 antibodies; neutralizing antibody assessments to be performed in samples positive for ADA

  9. Number and Percentage of Participants with Detectable Systemic Cytokine Concentrations [ Time Frame: Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 15, 50 ]
    Interferon-gamma, interleukin-1 beta, interleukin-2, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-13, interleukin-17, interleukin-12 p70 (heterodimer composed of p40 and p35 subunits), tumor necrosis factor-alpha

  10. Maximum Plasma Concentration (Cmax) [ Time Frame: Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 ]
    The observed maximum plasma concentration

  11. Time of Observed Maximum Plasma Concentration (Tmax) [ Time Frame: Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 ]
    Time at which the observed maximum plasma concentration occurred

  12. Terminal Elimination Rate Constant [ Time Frame: Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 ]
    Terminal elimination rate constant, determined using the linear least squares regression of the terminal phase of the log plasma concentration time profile

  13. Terminal Elimination Half-life [ Time Frame: Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 ]
    Elimination half-life calculated using terminal phase plasma concentration data

  14. Area Under the Plasma Concentration Versus Time Curve (AUC) from Time Zero to Time of Last Observed Quantifiable Concentration [ Time Frame: Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 ]
    Area under the plasma concentration versus time curve (AUC) from time zero to time of last observed quantifiable concentration (different from AUC from time zero to infinity)

  15. AUC from Time Zero to Infinity [ Time Frame: Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 ]
    Area under the plasma concentration versus time curve from time zero to infinity

  16. Total Clearance (CL) [ Time Frame: Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 ]
    Total clearance from plasma

  17. Terminal Volume of Distribution (Vz) [ Time Frame: Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 ]
    Apparent volume of distribution in the terminal phase

  18. Bioavailability (F) [ Time Frame: Day 1 (0, 1, 3, 5, 8 hours) and Days 2 (24 hours), 3, 4, 5, 6, 7, 8, 15, 22, 29, 50 ]
    Absolute bioavailability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to understand the key components of the study as described in the written informed consent document, and willing and able to provide written informed consent;
  2. Self-described healthy male or female, 18 to 65 years of age, inclusive, at Screening;
  3. Body mass index (BMI) within the range of 18.5 to <35 kg/m2 at Screening;
  4. If female, is surgically sterile, 2 years postmenopausal, or, if of childbearing potential, is using a medically accepted method of contraception (abstinence, the simultaneous use of 2 barrier methods, or the use of an intrauterine device [in place at least 3 months prior to dosing], or oral contraceptives), and agrees to continued use of this method until study Day 50;
  5. If male, agrees to use an approved method of contraception (abstinence, 2 barrier methods, female partner's use of an intrauterine device [in place at least 3 months prior to dosing], oral contraceptives or female partner who is surgically sterile or 2 years postmenopausal) and agrees to use this method until study Day 50;
  6. Able to comply with all study procedures, including the required overnight stays in the clinical research center and the food, beverage, and medication restrictions during the study;
  7. In the opinion of the Investigator, is able to adhere to the requirements of the study.

Exclusion Criteria:

  1. Known allergy to study medication or its components (non-medicinal ingredients) or a history of a severe allergic reaction to any drug or history of multiple food/drug allergies;
  2. Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening;
  3. History of alcohol or illicit drug use disorder, marijuana consumption as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, or a reported habitual alcohol intake greater than 1.5 oz (ethanol equivalent) per day (eg, 24 oz of beer, 10 oz of wine, or 3 oz of hard liquor) for the past two years;
  4. Positive urine screen for drugs of abuse including tetrahydrocannabinol or has a positive breathalyzer test on admission to the study center, at Screening and at Baseline for each treatment cohort;
  5. Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV), or positive for EBV polymerase chain reaction [PCR] at Screening;
  6. Negative for Epstein-Barr Virus ([EBV], viral capsid antigen [VCA IgG], Epstein-Barr nuclear antigen antibody [EBNA],);
  7. History of inadequately treated active or latent mycobacterium tuberculosis (TB) infection or positive QuantiFERON® TB Gold at Screening;
  8. History of diabetes, clinically significant cardiovascular, pulmonary, hepatic, renal, or malabsorptive disease, as determined by the Principal Investigator (PI);
  9. Clinically significant abnormality upon physical examination at Screening, as determined by the Investigator;
  10. Clinically significant abnormality on 12-lead ECG at Screening, as determined by the Investigator;
  11. Clinically significant abnormal laboratory values (clinical chemistry, hematology, coagulation, or urinalysis) outside the reference values established by the laboratory, as determined by the Investigator at Screening;
  12. Positive pregnancy test or lactating at Screening or at Day -1;
  13. Participation in an investigational study within 30 days or within 5 half-lives of the investigational drug, whichever is longer, prior to the Screening Visit;
  14. Receiving any antibody or biologic medicinal product within 90 days prior to Screening;
  15. Blood or plasma donation within 72 hours prior to Screening or planned up to study Day 50;
  16. Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen testing or equivalent testing on Day -1; Subjects fully recovered from coronavirus disease 2019 (COVID-19) infection are eligible. Subjects with a past history of hospitalization due to COVID-19 infection will be excluded;
  17. History of infection or vaccination within 90 days prior to the Screening, or planned vaccination within 90 days of dosing, with the exception of vaccination against SARS CoV-2;
  18. History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05238493


Contacts
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Contact: Pamela Allton 617-970-8104 pal@veloxis.com

Locations
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United States, Ohio
CTI Clinical Research Center Recruiting
Cincinnati, Ohio, United States, 45212
Sponsors and Collaborators
Veloxis Pharmaceuticals
Investigators
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Study Director: Shailesh G. Chavan, MD Veloxis Pharmaceuticals
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Responsible Party: Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05238493    
Other Study ID Numbers: VEL-101.KI102
First Posted: February 14, 2022    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No