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

NCT ID: NCT02858973

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-05-08

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

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Q203

Q203 tablets

Group Type: EXPERIMENTAL

Q203

Intervention Type: DRUG

Placebo

Placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Q203

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qurient Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

Q203-TB-PI-US002

Identifier Type: -

Identifier Source: org_study_id