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NCT04075175 · ClinicalTrials.gov registry record · Phase 1
Evaluate the Safety Pharmacokinetics of a Human Monoclonal Antibody S315 Against Diphtheria Toxin in Healthy Subjects
A Phase 1 study, sponsored by MassBiologics.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT04075175: Completed Phase 1 study, sponsored by MassBiologics.
NCT04075175 is a Phase 1 study that has completed, run by MassBiologics. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04075175, a Phase 1 study, has completed, sponsored by MassBiologics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
This study will examine the use of a single infusion of S315 at different doses in healthy volunteers to help understand its safety and tolerability. S315 is a monoclonal antibody that is being developed for treatment of diphtheria. The study will assess for any side effects when S315 and will also look at the levels of S315 in the blood over time.
Primary Outcome
Adverse events assessed for safety
Interventions
- DRUG S315
- DRUG 0.9% Sodium Chloride (NaCl)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2019-04-23 |
| Est. Completion | 2019-10-07 |
| Phase | Phase 1 |
What the finished NCT04075175 record still lists
NCT04075175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which S315 is the first listed.
NCT04075175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04075175 about?
NCT04075175 is a clinical study titled "Evaluate the Safety Pharmacokinetics of a Human Monoclonal Antibody S315 Against Diphtheria Toxin in Healthy Subjects". This study will examine the use of a single infusion of S315 at different doses in healthy volunteers to help understand its safety and tolerability. S315 is a monoclonal antibody that is being developed for treatment of diphtheria. The study will assess for any side effects when S315 and will also ...
What is the current status of trial NCT04075175?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2019-04-23. Estimated completion is 2019-10-07.
What interventions are being tested in trial NCT04075175?
The interventions under investigation include: S315 (DRUG), 0.9% Sodium Chloride (NaCl) (DRUG).
Who is sponsoring clinical trial NCT04075175?
This trial is sponsored by MassBiologics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04075175's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 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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