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

NCT05238493 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-06-27

No results posted yet for this study

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

Interventions

DRUG

VEL-101

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Libbie McKenzie, MD · Veloxis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-26
Primary Completion
2023-01-03
Completion
2023-01-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05238493 on ClinicalTrials.gov