A Study to Evaluate Safety, Tolerability and Pharmacokinetics of DA-8010 in Healthy Subjects

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: DA-8010

Criteria

Inclusion Criteria:

• BMI between 18.0 and 32.0 kg/m2

• Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria:

• Subjects who do not agree to use a method of acceptable contraception

• Female subjects of child-bearing potential who do not agree to use a highly effective method of birth control

• Consume more than 28 or 21 units of alcohol per week if male or female, respective

• Subjects who have used nicotine-containing products (including cigarettes), within 3 months prior to the first dose administration

• Subjects who have used, or intend to use the product like non-prescribed systemic or topical medication, herbal remedy, vitamin/mineral supplement, within 7 days of the first dose administration

• Systolic blood pressure < 90 mmHg or > 140 mmHg

• Diastolic blood pressure < 50 mmHg or > 90 mmHg

• Pulse rate < 45 bpm or > 100 bpm

• Positive urine drugs of abuse screen at screening or first admission

• Positive alcohol breath test at screening or first admission

• Positive cotinine test at screening or first admission

• Abnormality in the 12-lead ECG at screening, admission or predose on Day 1

• Subjects who are pregnant, breastfeeding, or lactating

• Subjects who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of any investigational drug in the past 3 months prior to the first dose administration

• Subjects who have a significant history of drug allergy, as determined by the Investigator

• Aspartate aminotransferase and/or Alanine aminotransferase ≥ 1.5 × upper limit of normal (ULN) or total bilirubin > ULN at screening or admission

• Subjects who are carriers of HBsAg or hepatitis C antibody, have serum hepatitis or positive result for the test for HIV antibodies