Healthy
Conditions
Keywords
Safety, Pharmacokinetics, Food Effect
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.
Interventions
DRUGDS102
DRUGPlacebo
Sponsors
DS Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a single dose | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 42 days | Phase I study - Overall PK of product in first in man study |
Countries
Ireland
Outcome results
None listed