- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04075175
Evaluate the Safety Pharmacokinetics of a Human Monoclonal Antibody S315 Against Diphtheria Toxin in Healthy Subjects (S315)
A Phase 1 Study in Healthy Subjects to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (mAb) S315 Against Diphtheria Toxin
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21225
- PAREXEL Early Phase Clinical Unit
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
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.
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
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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
|
Human monoclonal antibody against Diphtheria Toxin
|
Comparatore placebo: 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
|
Placebo 0.9% Sodium Chloride (NaCl)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
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.
Lasso di tempo: Day -1 through Day 60
|
Adverse events assessed for safety
|
Day -1 through Day 60
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Serial measurements of S315 concentration in the serum.
Lasso di tempo: 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
|
Pharmacokinetics
|
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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ronald Goldwater, MD, Parexel
- Direttore dello studio: John Z Sullivan-Bólyai, MD, MPH, MassBiologics of the University of Massachusetts
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MBL-DIPH-19-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .