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

• ClinicalTrials.gov Identifier: NCT02858973
• Recruitment Status: Completed
• First Posted: August 8, 2016
• Last Update Posted: May 14, 2018
• Sponsor: Qurient Co., Ltd.
• Information provided by (Responsible Party): Qurient Co., Ltd.

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)
• Actual Enrollment: 47 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
• Actual Primary Completion Date: May 2018
• Actual Study Completion Date: May 8, 2018

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

• 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

Locations

United States, Nebraska

Lincoln, Nebraska, United States, 68502

Sponsors and Collaborators

Qurient Co., Ltd.

More Information

• Responsible Party: Qurient Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02858973
• Other Study ID Numbers: Q203-TB-PI-US002
• First Posted: August 8, 2016
• Last Update Posted: May 14, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No