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

NCT05238493 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: VEL-101.KI102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• Number and Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)

  Number and percentage of participants experiencing one or more adverse events which occurred or worsened in severity after initiation of investigational product (IP) dosing

  Day 1 through Day 50

• Number and Percentage of Participants with Serious TEAEs

  Number and percentage of participants experiencing one or more serious TEAEs

  Day 1 through Day 50

• Number and Percentage of Participants with Grade 3 or Higher TEAEs

  Number and percentage of participants experiencing one or more grade 3 TEAEs

  Day 1 through Day 50

• Number and Percentage of Participants with TEAEs Leading to Withdrawal from the Study

  Number of participants experiencing one or more TEAEs directly resulting in withdrawal from the study

  Day 1 through Day 50

• Number and Percentage of Participants with TEAEs Leading to Death

  Number and percentage of participants experiencing TEAEs that resulted in death

  Day 1 through Day 50

Secondary Outcomes (18)

• Number and Percentage of Participants with Abnormal Chemistry Panel Results

  Days -1, 2 (24 hours), 3, 5, 8, 15, 22, 29, 50

• Number and Percentage of Participants with Abnormal Hematology Panel Results

  Days -1, 2 (24 hours), 3, 5, 8, 15, 22, 29, 50

• Number and Percentage of Participants with Abnormal Coagulation Panel Results

  Days -1, 2 (24 hours), 3, 5, 8, 15, 22, 29, 50

• Number and Percentage of Participants with Abnormal Urinalysis Results

  Days -1, 2 (24 hours), 3, 5, 8, 15, 22, 29, 50

• Number and Percentage of Participants with Abnormal 12-lead Electrocardiogram (ECG) Results

  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

Study Arms (8)

Subcutaneous (SQ) Dose "A"

EXPERIMENTAL

Single dose of VEL-101 by SQ injection

Drug: VEL-101

Intravenous (IV) Dose "A"

EXPERIMENTAL

Single dose of VEL-101 by IV infusion

Drug: VEL-101

SQ Dose "B"

EXPERIMENTAL

Single dose of VEL-101 by SQ injection

Drug: VEL-101

SQ Dose "C"

EXPERIMENTAL

Single dose of VEL-101 by SQ injection

Drug: VEL-101

IV Dose "C"

EXPERIMENTAL

Single dose of VEL-101 by IV infusion

Drug: VEL-101

SQ Dose "D"

EXPERIMENTAL

Single dose of VEL-101 by SQ injection

Drug: VEL-101

SQ Dose "E"

EXPERIMENTAL

Single dose of VEL-101 by SQ injection

Drug: VEL-101

SQ or IV Placebo

PLACEBO COMPARATOR

Single dose of Placebo by SQ injection or IV infusion

Drug: Placebo

Interventions

VEL-101 DRUG

Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1

IV Dose "C"; Intravenous (IV) Dose "A"; SQ Dose "B"; SQ Dose "C"; SQ Dose "D"; SQ Dose "E"; Subcutaneous (SQ) Dose "A"

Placebo DRUG

Intervention administered via subcutaneous injection or 1-hour intravenous infusion on Day 1

SQ or IV Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Self-described healthy male or female, 18 to 65 years of age, inclusive, at Screening;
• Body mass index (BMI) within the range of 18.5 to \<35 kg/m2 at Screening;
• 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;
• 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;
• 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;
• In the opinion of the Investigator, is able to adhere to the requirements of the study.

You may not qualify if:

• 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;
• Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening;
• 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;
• 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;
• 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;
• Negative for Epstein-Barr Virus (\[EBV\], viral capsid antigen \[VCA IgG\], Epstein-Barr nuclear antigen antibody \[EBNA\],);
• History of inadequately treated active or latent mycobacterium tuberculosis (TB) infection or positive QuantiFERON® TB Gold at Screening;
• History of diabetes, clinically significant cardiovascular, pulmonary, hepatic, renal, or malabsorptive disease, as determined by the Principal Investigator (PI);
• Clinically significant abnormality upon physical examination at Screening, as determined by the Investigator;
• Clinically significant abnormality on 12-lead ECG at Screening, as determined by the Investigator;
• 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;
• Positive pregnancy test or lactating at Screening or at Day -1;
• 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;
• Receiving any antibody or biologic medicinal product within 90 days prior to Screening;
• Blood or plasma donation within 72 hours prior to Screening or planned up to study Day 50;

Sponsors & Collaborators

• Veloxis Pharmaceuticals: lead

Study Sites (1)

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Study Officials

• Libbie McKenzie, MD

  Veloxis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 14, 2022
• Study Start: April 26, 2022
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)