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Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673593
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
DS Biopharma

Tracking Information
First Submitted Date  ICMJE January 21, 2016
First Posted Date  ICMJE February 4, 2016
Last Update Posted Date February 4, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a single dose [ Time Frame: 14 days ]
    Phase I study - Overall safety of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by Cmax) of DS102 administered as a single dose [ Time Frame: 14 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by tmax) of DS102 administered as a single dose [ Time Frame: 14 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by AUC0-inf) of DS102 administered as a single dose [ Time Frame: 14 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by AUClast) of DS102 administered as a single dose [ Time Frame: 14 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by CL/F) of DS102 administered as a single dose [ Time Frame: 14 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by Vz/F ) of DS102 administered as a single dose [ Time Frame: 14 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by t½) of DS102 administered as a single dose [ Time Frame: 14 days ]
    Phase I study - Overall PK of product in first in man study
  • Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a multiple dose for 28 days [ Time Frame: 42 days ]
    Phase I study - Overall safety of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by Cmax) of DS102 administered as a multiple dose [ Time Frame: 42 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by tmax) of DS102 administered as a multiple dose [ Time Frame: 42 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by AUC0-inf) of DS102 administered as a multiple dose [ Time Frame: 42 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by AUClast) of DS102 administered as a multiple dose [ Time Frame: 42 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by CL/F) of DS102 administered as a multiple dose [ Time Frame: 42 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by Vz/F) of DS102 administered as a multiple dose [ Time Frame: 42 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by AUC 0-24) of DS102 administered as a multiple dose [ Time Frame: 42 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by Css) of DS102 administered as a multiple dose [ Time Frame: 42 days ]
    Phase I study - Overall PK of product in first in man study
  • Pharmacokinetics (Plasma concentrations assessed by t½) of DS102 administered as a multiple dose [ Time Frame: 42 days ]
    Phase I study - Overall PK of product in first in man study
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects
Official Title  ICMJE A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Dose Phase I Study to Assess the Safety, Pharmacokinetics and Effect of Food on Orally Administered DS102 in Healthy Subjects
Brief Summary

The purpose of the study is to investigate the safety, pharmacokinetics and food effect of DS102 (up to 2000mg single and multiple daily doses) and placebo in healthy participants.

DS102 capsules will be orally administered for up to 4 weeks, and will be compared against placebo.

The study will enrol approximately 56 adult subjects.

Detailed Description

There will be 7 cohorts enrolled, each consisting of 8 subjects.

Cohorts 1 - 4 will be orally administered up to 2000mg single doses of DS102 on Day 1.

Cohorts 5 - 7 will be orally administered up to 2000mg multiple daily doses of DS102 for 28 days.

The primary objective is to assess the safety and plasma pharmacokinetics of single and multiple daily oral doses of DS102.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: DS102
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Taken orally as a single dose (Cohorts 1 - 4) Taken orally as a multiple daily dose for 28 days (Cohorts 5 - 7)
    Intervention: Drug: Placebo
  • Experimental: DS102 100mg Single Dose
    Taken orally once by Cohort 1
    Intervention: Drug: DS102
  • Experimental: DS102 500mg Single Dose
    Single Dose taken orally on three separate occasions by Cohort 2 (second and third dose assessing food effect)
    Intervention: Drug: DS102
  • Experimental: DS102 1000mg Single Dose
    Taken orally once by Cohort 3
    Intervention: Drug: DS102
  • Experimental: DS102 2000mg Single Dose
    Taken orally once by Cohort 4
    Intervention: Drug: DS102
  • Experimental: DS102 500mg Multiple Dose
    Taken orally once a day for 28 days by Cohort 5
    Intervention: Drug: DS102
  • Experimental: DS102 1000mg Multiple Dose
    Taken orally once a day for 28 days by Cohort 6
    Intervention: Drug: DS102
  • Experimental: DS102 2000mg Multiple Dose
    Taken orally once a day for 28 days by Cohort 7
    Intervention: Drug: DS102
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2016)
57
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is male or female and is aged between 18 and 45 years inclusive.
  • Subject's body mass index (BMI) is between 18.0 and 30.0 kg/m2 inclusive.
  • Subject is a non-smoker, has been a non-smoker for 3 months prior to screening and has a negative urine cotinine test at screening.

Exclusion Criteria:

  • Subject has had a clinically significant illness in the 4 weeks before screening.
  • Use of prescribed medication in the 2 weeks before dosing or over-the-counter preparations (including vitamins and supplements) for 1 week before dosing
  • Subject has a significant history of drug/solvent abuse, or a positive drugs of abuse (DOA) test at screening or Day -1.
  • Subject with a history of alcohol abuse in the opinion of the Investigator, or who currently drinks in excess of 28 units per week (males) or 21 units per week (females), whereby a unit consists of 10ml or 8mg of pure alcohol, or who have a positive alcohol urine test at screening or Day -1.
  • Subject has participated in any other clinical study with an investigational drug/device within 3 months before the first day of administration of study treatment.
  • Subject has a positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibodies at screening.
  • Subject has had a serious adverse reaction or significant hypersensitivity to any drug.
  • Subject has donated blood or blood products within 3 months before screening.
  • Subject has known hypersensitivity to any ingredients of the study treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02673593
Other Study ID Numbers  ICMJE DS102A-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DS Biopharma
Study Sponsor  ICMJE DS Biopharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account DS Biopharma
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP