Single and Multiple Dose Evaluation of QBKPN SSI In Healthy Volunteers
23. august 2017 oppdatert av: Qu Biologics Inc.
A Placebo-Controlled, Blinded, Dose-Escalation, Study to Assess the Safety and Pharmacodynamics of Single and Multiple Doses of QBKPN (Inactivated Klebsiella Pneumoniae) Site Specific Immunomodulator (SSI), Administered Subcutaneously to Healthy Male and Female Volunteers
The purpose of this dose-escalation study is to assess the safety and pharmacodynamics of single and multiple doses of QBKPN SSI, administered subcutaneously to healthy adult volunteers
Studieoversikt
Studietype
Intervensjonell
Fase
- Fase 1
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy, non-smoking (at least for 6 months prior to first study drug administration) males or females, 18 to 65 years of age, inclusive at the time of informed consent.
- Body mass index (BMI) that is within 18.5 - 30.0 kg/m2, inclusive.
- Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination
- Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
- QTc interval ≤ 450 milliseconds for males and females, unless deemed otherwise Not Clinically Significant by the Principal Investigator/Sub-Investigator.
- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
- Agree not to have a tattoo or body piercing until the end of the study.
- Agree to practice effective methods of contraception
Exclusion Criteria:
- Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
- A known history or positive test result for human immunodeficiency virus (HIV), chronic Hepatitis B surface antigen, or Hepatitis C.
- A positive test result for drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol test and cotinine. Positive pregnancy test for female subjects.
- Known history or presence of (1) Alcohol abuse or dependence within one year prior to first study drug administration; (2) Drug abuse or dependence; (3) Known or suspected hypersensitivity to any component of the product (4) Food allergies and/or presence of any dietary restrictions; or (5) Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
- Recent history (within 8 weeks prior to screening) of travel to or emigration from any country with high incidence for tuberculosis.
- A positive tuberculin skin (PPD) test result
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: SAD Cohort 1
Single dose of 0.05 mL QBKPN or Placebo
|
Placebo
QBKPN Site Specific Immunomodulators
|
|
Eksperimentell: SAD Cohort 2
Single dose of 0.10 mL QBKPN or Placebo
|
Placebo
QBKPN Site Specific Immunomodulators
|
|
Eksperimentell: SAD Cohort 3
Single dose of 0.20 mL QBKPN or Placebo
|
Placebo
QBKPN Site Specific Immunomodulators
|
|
Eksperimentell: SAD Cohort 4
Single dose of 0.40 mL QBKPN or Placebo
|
Placebo
QBKPN Site Specific Immunomodulators
|
|
Eksperimentell: SAD Cohort 5
Single dose of 0.80 mL QBKPN or Placebo
|
Placebo
QBKPN Site Specific Immunomodulators
|
|
Eksperimentell: SAD Cohort 6
Single dose of 1.2 mL QBKPN or Placebo
|
Placebo
QBKPN Site Specific Immunomodulators
|
|
Eksperimentell: MAD Cohort 1
5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)
|
Placebo
QBKPN Site Specific Immunomodulators
|
|
Eksperimentell: MAD Cohort 2
5 doses of QBKPN or Placebo administered every other day (using one of the dose from the SAD Cohort)
|
Placebo
QBKPN Site Specific Immunomodulators
|
|
Eksperimentell: MAD Cohort 3
5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)
|
Placebo
QBKPN Site Specific Immunomodulators
|
|
Eksperimentell: MAD Cohort 4
5 doses of QBKPN or Placebo administered every day (using one of the dose from the SAD Cohort)
|
Placebo
QBKPN Site Specific Immunomodulators
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
Tidsramme: 2 weeks
|
Incidence, severity, and dose-relationship of adverse events, vital signs, and clinical laboratory parameters
|
2 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in cellular biomarkers over time
Tidsramme: 2 weeks
|
Absolute (#/mL) and Differentials (%)
|
2 weeks
|
|
Immunological biomarkers analysis
Tidsramme: 2 weeks
|
2 weeks
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
MAD Cohorts only: Changes in cell surface markers on neutrophils and monocytes over time
Tidsramme: 2 weeks
|
2 weeks
|
|
MAD cohorts only: Gene Expression Analysis
Tidsramme: 2 weeks
|
2 weeks
|
|
Phenotype and Genotype Correlation [Exploratory gene association analysis]
Tidsramme: 2 weeks
|
2 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2016
Primær fullføring (Forventet)
1. februar 2017
Studiet fullført (Forventet)
1. februar 2017
Datoer for studieregistrering
Først innsendt
19. august 2016
Først innsendt som oppfylte QC-kriteriene
7. september 2016
Først lagt ut (Anslag)
13. september 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- QBKPN-03
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