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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: Completed Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03719443 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number adverse events (AEs), serious adverse events (SAEs), and drug related events following administration of VIS649. Safety will be assessed via AE severity per CTCAE v4.0
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 |
What the finished NCT03719443 record still lists
NCT03719443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03719443 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03719443's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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