Trials / Completed
CompletedNCT04075175
Evaluate the Safety Pharmacokinetics of a Human Monoclonal Antibody S315 Against Diphtheria Toxin in Healthy Subjects
A Phase 1 Study in Healthy Subjects to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (mAb) S315 Against Diphtheria Toxin
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- MassBiologics · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | S315 | Human monoclonal antibody against Diphtheria Toxin |
| DRUG | 0.9% Sodium Chloride (NaCl) | Placebo 0.9% Sodium Chloride (NaCl) |
Timeline
- Start date
- 2019-04-23
- Primary completion
- 2019-10-07
- Completion
- 2019-10-07
- First posted
- 2019-08-30
- Last updated
- 2020-02-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04075175. Inclusion in this directory is not an endorsement.