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DiphtheriaPhase 1S315NCT04075175

Evaluate the Safety Pharmacokinetics of a Human Monoclonal Antibody S315 Against Diphtheria Toxin in Healthy Subjects

A Phase 1 study testing S315 and 0.9% Sodium Chloride (NaCl) in people with Diphtheria, run by MassBiologics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Diphtheria
What is being tested?
S315 and 0.9% Sodium Chloride (NaCl)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteUnited States
Study dates
23 Apr 2019to 7 Oct 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Capable of giving written informed consent and able to effectively communicate with the Investigator and study personnel. A signed informed consent document (ICD) must be on file prior to initiating the screening procedures.
  • Willing and able to complete all study requirements, restrictions, visits and procedures.
  • Age 18 to 55 years, inclusive.
  • Weight 50 kg to 90 kg, inclusive.
  • Systolic blood pressure less than 140 mmHg and diastolic less than 90 mmHg on two separate readings at least one minute apart.
  • Women of child bearing potential, defined as all women physiologically capable of becoming pregnant must agree not to become pregnant and must use a method of birth control during the entire study.
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  • Women of non-child bearing potential may be included. Women are considered post-menopausal and not of childbearing potential if, they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile or have had surgical total hysterectomy or tubal ligation at least six weeks ago.
  • Males of reproductive potential must use a barrier method of contraception during the course of the study.
  • Screening laboratory values must meet the following criteria:
  • White blood cell (WBC) 3.5 - Upper Limit of Normal (ULN)
  • Platelets > 100,000/mm3
  • Hemoglobin ≥ Lower Limit of Normal (LLN)
  • Creatinine ≤ ULN
  • Aspartate Aminotransferase (AST) ≤ ULN
  • Alanine Aminotransferase (ALT) ≤ ULN
  • Alkaline Phosphatase ≤ ULN
  • Bilirubin ≤ ULN
  • HgbA1c

Who cannot join

  • 1. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
  • 2. History of or any current medical condition that could compromise the safety of the participant in the study, as determined by the Investigator.
  • 3. History of suicidal behavior within 12 months prior to screening.
  • 4. Donated blood or plasma within 60 days prior to dosing.
  • 5. Clinically significant gastrointestinal, cardiovascular, neurologic, psychiatric, substance abuse, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease, as determined by the Investigator.
  • 6. Drug or alcohol abuse within previous 12 months or a positive test at screening and at Day -1 within 24 hours of study product administration.
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  • 7. History of a previous severe allergic reaction with generalized urticaria, angioedema or anaphylaxis.
  • 8. Physical finding on examination considered clinically significant such as murmur (other than functional), hepatosplenomegaly, lymphadenopathy or focal neurological deficit.
  • 9. Urinalysis positive for > trace protein, > 5 Red Blood Cell (RBC)/hpf or > 5 WBC/hpf.
  • 10. Positive serology for HIV antibody, Hepatitis C Virus (HCV) antibody or Hepatitis B surface antigen at screening.
  • 11. Positive serum pregnancy test during screening or within 24 hours of study product administration, or an unwillingness to undergo pregnancy testing.
  • 12. Pregnant within 6 months or breast-feeding within 3 months prior to screening.
  • 13. Receipt of licensed vaccine containing diphtheria toxoid (Td, Tdap, pneumococcal conjugate vaccines, meningococcal conjugate vaccines) within the last year.
  • 14. Treatment with another investigational drug or other intervention within 30 days from screening.
  • 15. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study.
  • 16. Safety laboratory abnormalities at Screening or Day -1, which are clinically significant as determined by the Investigator.
  • 17. Tobacco, e-cigarettes, and/or nicotine use within 30 days prior to screening confirmed by urine cotinine test.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Parexel Early Phase Clinical Unit

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Phase 1 Study in Healthy Subjects to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (mAb) S315 Against Diphtheria Toxin

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
Diphtheria
Being tested
S315, 0.9% Sodium Chloride (NaCl)
Medical subject headings
Diphtheria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S315Drug

    Human monoclonal antibody against Diphtheria Toxin

  • 0.9% Sodium Chloride (NaCl)Drug

    Placebo 0.9% Sodium Chloride (NaCl)

Study groups in NCT04075175
Study groupRoleWhat they receive
S315 human monoclonal antibodyExperimental5 cohorts of 8 subjects each randomized 6:2 (S315:Placebo (0.9% Sodium Chloride)) with escalation of a fixed dose of S315
Receives: Drug: S315
0.9% sodium chloride (NaCl)Placebo comparator5 cohorts of 8 subjects each randomized 6:2 (S315:Placebo(0.9% Sodium Chloride)) with escalation of a fixed dose of S315
Receives: Drug: 0.9% Sodium Chloride (NaCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of Participants with adverse events as assessed by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table (Draft revised November 2007) adapted by the Division of Microbiology and Infectious Diseases, NIAID, NIH.

    Adverse events assessed for safety

    Measured: Day -1 through Day 60

Secondary outcomes (1)

  1. Serial measurements of S315 concentration in the serum.

    Pharmacokinetics

    Measured: Day 1 pre-dose and Day 1, Day 2, Day 4, Day 8, Day 15, Day 22, day 29, Day 43 and Day 60 post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2019
  2. Study start23 Apr 2019
  3. Primary completion7 Oct 2019
  4. Study completion7 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04075175
Sponsor's protocol ID
MBL-DIPH-19-01
Acronym
S315
Status last verified
Feb 2020
First submitted
15 Aug 2019
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Smith HL, Cheslock P, Leney M, Barton B, Molrine DC. Potency of a human monoclonal antibody to diphtheria toxin relative to equine diphtheria anti-toxin in a guinea pig intoxication model. Virulence. 2016 Aug 17;7(6):660-8. doi: 10.1080/21505594.2016.1171436. Epub 2016 Apr 12.

    PubMed 27070129

  • Sullivan-Bolyai JZ, Allen LB, Cannon R, Cohane KP, Dunzo E, Goldwater R, StCyr K, Wang Y, Klempner MS. A Phase 1 Study in Healthy Subjects to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (S315) Against Diphtheria Toxin. J Infect Dis. 2025 Sep 15;232(3):534-539. doi: 10.1093/infdis/jiae499.

    PubMed 39570031

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing S315 and 0.9% Sodium Chloride (NaCl) in people with Diphtheria, run by MassBiologics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of Participants with adverse events as assessed by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table (Draft revised November 2007) adapted by the Division of Microbiology and Infectious Diseases, NIAID, NIH. (time frame: Day -1 through Day 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04075175, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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