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A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT02858973
Recruitment Status : Recruiting
First Posted : August 8, 2016
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Q203 Drug: Placebo Phase 1

Detailed Description:

Six (6) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive multiple oral doses of Q203 or placebo for 14 days QD with a standard meal. Subjects will participate in only one cohort.

Safety (i.e., physical examinations, vital signs, ECGs, clinical laboratory tests, and adverse events [AEs]) will be assessed throughout the study; serial blood and urine samples will be collected for these assessments. Blood samples will also be collected for the PK assessment of Q203.

Escalation to the next dose level (i.e., initiation of the next cohort) will not take place until the Principal Investigator (PI), medical monitor, and representatives of the Sponsor have reviewed all available safety and tolerability from the previous cohorts and agree to the initiation of the next cohort.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1B, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Q203 When Administered Orally to Healthy Adult Subjects
Study Start Date : August 2016
Estimated Primary Completion Date : December 2017
Arms and Interventions

Arm Intervention/treatment
Experimental: Q203
Q203 tablets
Drug: Q203
Placebo Comparator: Placebo
Placebo tablets
Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring [ Time Frame: 16 days post dose ]

Secondary Outcome Measures :
  1. Pharmacokinetic analysis: Area under the curve [ Time Frame: 16 days post dose ]
  2. Pharmacokinetic analysis: Maximum observed plasma drug concentration [ Time Frame: 16 days post dose ]
  3. Pharmacokinetic analysis: Time of maximum observed concentration [ Time Frame: 16 days post dose ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
  2. Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.

Exclusion Criteria:

  1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
  2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
  3. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858973


Contacts
Contact: June Kim jkim@qurient.com

Locations
United States, Nebraska
Recruiting
Lincoln, Nebraska, United States, 68502
Contact: Jiye Ahn       jahn@qurient.com   
Sponsors and Collaborators
Qurient Co., Ltd.
More Information

Responsible Party: Qurient Co., Ltd.
ClinicalTrials.gov Identifier: NCT02858973     History of Changes
Other Study ID Numbers: Q203-TB-PI-US002
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No