Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: DS102

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: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• Ireland
  • Belfast, Ireland
    • DS Biopharma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Drug: Placebo
Experimental: DS102 100mg Single Dose; Taken orally once by Cohort 1	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)	Drug: DS102
Experimental: DS102 1000mg Single Dose; Taken orally once by Cohort 3	Drug: DS102
Experimental: DS102 2000mg Single Dose; Taken orally once by Cohort 4	Drug: DS102
Experimental: DS102 500mg Multiple Dose; Taken orally once a day for 28 days by Cohort 5	Drug: DS102
Experimental: DS102 1000mg Multiple Dose; Taken orally once a day for 28 days by Cohort 6	Drug: DS102
Experimental: DS102 2000mg Multiple Dose; Taken orally once a day for 28 days by Cohort 7	Drug: DS102

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a single dose	Phase I study - Overall safety of product in first in man study	14 days
Pharmacokinetics (Plasma concentrations assessed by Cmax) of DS102 administered as a single dose	Phase I study - Overall PK of product in first in man study	14 days
Pharmacokinetics (Plasma concentrations assessed by tmax) of DS102 administered as a single dose	Phase I study - Overall PK of product in first in man study	14 days
Pharmacokinetics (Plasma concentrations assessed by AUC0-inf) of DS102 administered as a single dose	Phase I study - Overall PK of product in first in man study	14 days
Pharmacokinetics (Plasma concentrations assessed by AUClast) of DS102 administered as a single dose	Phase I study - Overall PK of product in first in man study	14 days
Pharmacokinetics (Plasma concentrations assessed by CL/F) of DS102 administered as a single dose	Phase I study - Overall PK of product in first in man study	14 days
Pharmacokinetics (Plasma concentrations assessed by Vz/F ) of DS102 administered as a single dose	Phase I study - Overall PK of product in first in man study	14 days
Pharmacokinetics (Plasma concentrations assessed by t½) of DS102 administered as a single dose	Phase I study - Overall PK of product in first in man study	14 days
Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a multiple dose for 28 days	Phase I study - Overall safety of product in first in man study	42 days
Pharmacokinetics (Plasma concentrations assessed by Cmax) of DS102 administered as a multiple dose	Phase I study - Overall PK of product in first in man study	42 days
Pharmacokinetics (Plasma concentrations assessed by tmax) of DS102 administered as a multiple dose	Phase I study - Overall PK of product in first in man study	42 days
Pharmacokinetics (Plasma concentrations assessed by AUC0-inf) of DS102 administered as a multiple dose	Phase I study - Overall PK of product in first in man study	42 days
Pharmacokinetics (Plasma concentrations assessed by AUClast) of DS102 administered as a multiple dose	Phase I study - Overall PK of product in first in man study	42 days
Pharmacokinetics (Plasma concentrations assessed by CL/F) of DS102 administered as a multiple dose	Phase I study - Overall PK of product in first in man study	42 days
Pharmacokinetics (Plasma concentrations assessed by Vz/F) of DS102 administered as a multiple dose	Phase I study - Overall PK of product in first in man study	42 days
Pharmacokinetics (Plasma concentrations assessed by AUC 0-24) of DS102 administered as a multiple dose	Phase I study - Overall PK of product in first in man study	42 days
Pharmacokinetics (Plasma concentrations assessed by Css) of DS102 administered as a multiple dose	Phase I study - Overall PK of product in first in man study	42 days
Pharmacokinetics (Plasma concentrations assessed by t½) of DS102 administered as a multiple dose	Phase I study - Overall PK of product in first in man study	42 days

Collaborators and Investigators

• Sponsor: DS Biopharma

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Food Effect
• Other Study ID Numbers: DS102A-01