Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 15 February 2016
• Main ID: NCT02673593
• Date of registration: 21/01/2016
• Prospective Registration: No
• Primary sponsor: DS Biopharma
• Public title: Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects
• Scientific 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
• Date of first enrolment: July 2015
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02673593
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
• Phase: Phase 1

Countries of recruitment

Ireland

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: DS102

Drug: Placebo

Primary Outcome(s)

Pharmacokinetics (Plasma concentrations assessed by Vz/F) of DS102 administered as a multiple dose [Time Frame: 42 days]

Pharmacokinetics (Plasma concentrations assessed by CL/F) of DS102 administered as a multiple dose [Time Frame: 42 days]

Pharmacokinetics (Plasma concentrations assessed by CL/F) of DS102 administered as a single dose [Time Frame: 14 days]

Pharmacokinetics (Plasma concentrations assessed by Cmax) of DS102 administered as a multiple dose [Time Frame: 42 days]

Pharmacokinetics (Plasma concentrations assessed by AUC0-inf) of DS102 administered as a multiple dose [Time Frame: 42 days]

Pharmacokinetics (Plasma concentrations assessed by Cmax) of DS102 administered as a single dose [Time Frame: 14 days]

Pharmacokinetics (Plasma concentrations assessed by tmax) of DS102 administered as a multiple dose [Time Frame: 42 days]

Pharmacokinetics (Plasma concentrations assessed by t½) of DS102 administered as a multiple dose [Time Frame: 42 days]

Pharmacokinetics (Plasma concentrations assessed by tmax) of DS102 administered as a single dose [Time Frame: 14 days]

Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a multiple dose for 28 days [Time Frame: 42 days]

Pharmacokinetics (Plasma concentrations assessed by Css) of DS102 administered as a multiple dose [Time Frame: 42 days]

Pharmacokinetics (Plasma concentrations assessed by AUClast) of DS102 administered as a multiple dose [Time Frame: 42 days]

Pharmacokinetics (Plasma concentrations assessed by AUClast) of DS102 administered as a single dose [Time Frame: 14 days]

Pharmacokinetics (Plasma concentrations assessed by AUC0-inf) of DS102 administered as a single dose [Time Frame: 14 days]

Pharmacokinetics (Plasma concentrations assessed by Vz/F ) of DS102 administered as a single dose [Time Frame: 14 days]

Safety (adverse events, laboratory tests, vital signs, ECGs) of DS102 administered as a single dose [Time Frame: 14 days]

Pharmacokinetics (Plasma concentrations assessed by AUC 0-24) of DS102 administered as a multiple dose [Time Frame: 42 days]

Pharmacokinetics (Plasma concentrations assessed by t½) of DS102 administered as a single dose [Time Frame: 14 days]

Secondary ID(s)

DS102A-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors