Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03719443 · ClinicalTrials.gov registry record · Phase 1
First in Human Study to Assess Safety of VIS649 in Healthy Subjects
A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT03719443 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 51 participants.
The verdict
NCT03719443, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
This is a phase 1, randomized, placebo-controlled, double-blind, single ascending dose study of IV VIS649 in healthy subjects. VIS649 is a monoclonal immunoglobulin G2 (IgG2) antibody targeting the B-cell growth factor APRILL. The study will enroll up to 45 subjects and will be conducted in up to 5 sequential dosing cohorts at four different dose levels, enrolling 9 subjects per cohort. Subjects will be randomized to VIS649 or placebo in a ratio of 7:2 (7 active, 2 placebo). Safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from the initial cohorts will be assessed.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL VIS649
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2018-10-09 |
| Est. Completion | 2019-08-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03719443
The ClinicalTrials.gov registry entry for NCT03719443 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03719443 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03719443 about?
NCT03719443 is a clinical study titled "First in Human Study to Assess Safety of VIS649 in Healthy Subjects". This is a phase 1, randomized, placebo-controlled, double-blind, single ascending dose study of IV VIS649 in healthy subjects. VIS649 is a monoclonal immunoglobulin G2 (IgG2) antibody targeting the B-cell growth factor APRILL. The study will enroll up to 45 subjects and will be conducted in up to ...
What is the current status of trial NCT03719443?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2018-10-09. Estimated completion is 2019-08-10.
What interventions are being tested in trial NCT03719443?
The interventions under investigation include: Placebo (BIOLOGICAL), VIS649 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03719443?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.