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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT02858973

Run by

Qurient Co., Ltd.

People needed

47

Starts

2016-08-01

Expected to finish

2018-05-08

Last updated by the study team

2018-05-14

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
• 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.

Where it is running

• Study site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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