Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Taken orally as a single dose (Cohorts 1 - 4) Taken orally as a multiple daily dose for 28 days (Cohorts 5 - 7) |
|
| DS102 100mg Single Dose | Experimental | Taken orally once by Cohort 1 |
|
| DS102 500mg Single Dose | Experimental | Single Dose taken orally on three separate occasions by Cohort 2 (second and third dose assessing food effect) |
|
| DS102 1000mg Single Dose | Experimental | Taken orally once by Cohort 3 |
|
| DS102 2000mg Single Dose | Experimental | Taken orally once by Cohort 4 |
|
| DS102 500mg Multiple Dose | Experimental | Taken orally once a day for 28 days by Cohort 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS102 | Drug |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DS Biopharma Investigational Site | Belfast | Ireland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| DS102 1000mg Multiple Dose | Experimental | Taken orally once a day for 28 days by Cohort 6 |
|
| DS102 2000mg Multiple Dose | Experimental | Taken orally once a day for 28 days by Cohort 7 |
|
| Placebo | Drug |
|
| 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 |