Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Healthy Volunteers

2. mars 2018 oppdatert av: Genentech, Inc.

A PHASE I, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED, SINGLE-ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY,TOLERABILITY, AND PHARMACOKINETICS OF DSTA4637S IN HEALTHY VOLUNTEERS

This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers, enrolled at a single site in the United States to investigate the safety, tolerability, and pharmacokinetics of DSTA4637S.

Studieoversikt

Status

Fullført

Forhold

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Kansas
      • Lenexa, Kansas, Forente stater, 66219
        • PRA International Clinical Pharmacology Center (EDS US Clinic)

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:

  • Signed Informed Consent Form
  • Able to comply with the study protocol, in the investigator's judgment
  • Body mass index (BMI) between 18 and 32 kilogram per square meters (kg/m^2), inclusive
  • In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs
  • Clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor
  • Willing to abstain from the use of drugs of abuse through completion of the study
  • Willing to abstain from use of over the counter, herbal or prescription medications/products from 14 days prior to Day 1 through completion of the study, unless deemed acceptable by the investigator and Sponsor
  • Agreeable to, and deemed able to (by the investigator), comply with requirements of the study, including the follow-up period
  • Willing to abstain from consumption of alcohol-based products from 72 hours prior to Day 1 until Phase 1 unit check-out on Day 3 and for 72 hours prior to each follow-up visit
  • For women of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use non-hormonal contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 85 days after the last dose of study drug
  • For men, agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined in the study protocol

Exclusion Criteria:

  • Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that in the opinion of the investigator or Sponsor contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications
  • Use of tobacco, electronic cigarettes, personal vaporizer or electronic nicotine delivery systems (positive history within 3 months before initiation of dosing on Day 1)
  • Received any vaccine within 14 days prior to screening
  • Pregnant or lactating, or intending to become pregnant within 3 months after screening
  • Positive serum pregnancy test result at screening or Day −1
  • Received oral antibiotics within 4 weeks before initiation of dosing on Day 1, or intravenous antibiotics within 8 weeks before initiation of dosing
  • Hospitalization within 4 weeks before initiation of dosing
  • Positive for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody
  • History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine, and crack) within 1 year prior to screening
  • Positive drug screen at screening or Day -1
  • History of anaphylactic or hypersensitivity drug reaction, unless approved by the investigator and Sponsor
  • Blood transfusion within 8 weeks prior to screening
  • History of malignancy within 10 years of screening except completely excised basal cell carcinoma or squamous cell carcinoma of the skin
  • Donation of plasma (greater than or equal to [>=] 500 milliliter [mL]) within 7 days prior to study drug administration
  • Donation or loss of whole blood (excluding the volume of blood that will be drawn during screening procedures) as follows: 50-499 mL of whole blood within 30 days or greater than (>) 499 mL of whole blood within 56 days prior to study drug administration
  • Hemoglobin <128 gram per liter (g/L) (males) and <115 g/L (females) and hematocrit <0.37 L/L (males) and <0.32 L/L (females) at screening
  • Poor peripheral venous access
  • History or presence of an abnormal ECG that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, evidence of prior myocardial infarction
  • Exposure to any biological therapy or investigational biological agent within 90 days prior to the screening evaluation or have received any other investigational treatment 30 days prior to the screening evaluation (or within 5 half-lives of the investigational product, whichever is greater)
  • Any history of hypersensitivity or allergy to rifampin or other rifamycin analogs

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Participants will receive placebo matched to DSTA4637S intravenously on Day 1.
Eksperimentell: DSTA4637S
Participants will receive DSTA4637S intravenously on Day 1.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Number of Participants with at least 1 Adverse Event (AE)
Tidsramme: Up to Day 85
Up to Day 85

Sekundære resultatmål

Resultatmål
Tidsramme
Concentration of analytes of DSTA4637S in plasma and serum
Tidsramme: Up to Day 85
Up to Day 85
Concentration of anti-therapeutic antibodies (ATA) to DSTA4637S
Tidsramme: Up to Day 85
Up to Day 85

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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 (Faktiske)

29. november 2015

Primær fullføring (Faktiske)

30. mai 2016

Studiet fullført (Faktiske)

30. mai 2016

Datoer for studieregistrering

Først innsendt

3. november 2015

Først innsendt som oppfylte QC-kriteriene

3. november 2015

Først lagt ut (Anslag)

4. november 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. mars 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. mars 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • GV29259

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere