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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-23

Study Completion Date

2019-10-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)

NCT01202695

Anthrax

COMPLETED PHASE1

NasoShield in Healthy Adults to Study Safety and Immunogenicity

NCT04415749

Healthy Volunteers

COMPLETED PHASE1

A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants COVID-19 Vaccine

NCT05652543

COVID-19 Pandemic

COMPLETED PHASE2

A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults

NCT02115815

Respiratory Syncytial Virus (RSV)

COMPLETED PHASE1

A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557

NCT00578682

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diphtheria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

S315 human monoclonal antibody

5 cohorts of 8 subjects each randomized 6:2 (S315:Placebo (0.9% Sodium Chloride)) with escalation of a fixed dose of S315

Group Type EXPERIMENTAL

S315

Intervention Type DRUG

Human monoclonal antibody against Diphtheria Toxin

0.9% sodium chloride (NaCl)

5 cohorts of 8 subjects each randomized 6:2 (S315:Placebo(0.9% Sodium Chloride)) with escalation of a fixed dose of S315

Group Type PLACEBO_COMPARATOR

0.9% Sodium Chloride (NaCl)

Intervention Type DRUG

Placebo 0.9% Sodium Chloride (NaCl)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

S315

Human monoclonal antibody against Diphtheria Toxin

Intervention Type DRUG

0.9% Sodium Chloride (NaCl)

Placebo 0.9% Sodium Chloride (NaCl)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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.
2. Age 18 to 55 years, inclusive.
3. Weight 50 kg to 90 kg, inclusive.
4. Systolic blood pressure less than 140 mmHg and diastolic less than 90 mmHg on two separate readings at least one minute apart.
5. 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.

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.
6. Males of reproductive potential must use a barrier method of contraception during the course of the study.
7. 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

Exclusion Criteria

* 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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes