HealthyPhase 1NCT02673593
Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects
A Phase 1 study testing DS102 in people with Healthy, run by DS Biopharma at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DS102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteIreland
- Study dates
- Jul 2015to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- DS102, Placebo
- Keywords
- Safety, Pharmacokinetics, Food Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS102Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Placebo |
| DS102 100mg Single Dose | Experimental | Taken orally once by Cohort 1 Receives: Drug: DS102 |
| DS102 500mg Single Dose | Experimental | Single Dose taken orally on three separate occasions by Cohort 2 (second and third dose assessing food effect) Receives: Drug: DS102 |
| DS102 1000mg Single Dose | Experimental | Taken orally once by Cohort 3 Receives: Drug: DS102 |
| DS102 2000mg Single Dose | Experimental | Taken orally once by Cohort 4 Receives: Drug: DS102 |
| DS102 500mg Multiple Dose | Experimental | Taken orally once a day for 28 days by Cohort 5 Receives: Drug: DS102 |
| DS102 1000mg Multiple Dose | Experimental | Taken orally once a day for 28 days by Cohort 6 Receives: Drug: DS102 |
| DS102 2000mg Multiple Dose | Experimental | Taken orally once a day for 28 days by Cohort 7 Receives: Drug: DS102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- DS Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673593
- Sponsor's protocol ID
- DS102A-01
- Status last verified
- Jan 2016
- First submitted
- 21 Jan 2016
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02673593
- Acronym / sponsor ID
- DS102A-01
- Conditions
- Healthy
- Keywords
- Safety, Pharmacokinetics, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- DS BiopharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTaken 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 | Drug: DS102Taken orally once by Cohort 1 |
| DS102 500mg Single Dose | Experimental | Drug: DS102Single Dose taken orally on three separate occasions by Cohort 2 (second and third dose assessing food effect) |
| DS102 1000mg Single Dose | Experimental | Drug: DS102Taken orally once by Cohort 3 |
| DS102 2000mg Single Dose | Experimental | Drug: DS102Taken orally once by Cohort 4 |
| DS102 500mg Multiple Dose | Experimental | Drug: DS102Taken orally once a day for 28 days by Cohort 5 |
| DS102 1000mg Multiple Dose | Experimental | Drug: DS102Taken orally once a day for 28 days by Cohort 6 |
| DS102 2000mg Multiple Dose | Experimental | Drug: DS102Taken orally once a day for 28 days by Cohort 7 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS102 | Drug | DS102 1000mg Multiple Dose, DS102 1000mg Single Dose, DS102 100mg Single Dose, DS102 2000mg Multiple Dose, DS102 2000mg Single Dose, DS102 500mg Multiple Dose, DS102 500mg Single Dose |
| Placebo | Drug | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DS102 in people with Healthy, run by DS Biopharma at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a single dose (time frame: 14 days). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.