A Single and Multiple Ascending Dose Escalation and Food Effect Study of QX-4533 in Healthy Participants

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorQuantX Biosciences, Inc.

About this trial

The primary purpose of this study is to evaluate the safety and tolerability of QX-4533 following oral administration of single and multiple ascending doses in healthy participants.

Eligibility criteria

Qualifiers

Male or female between 18 and 55 years of age (inclusive) at screening.

Understands the study procedures and is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Willing and able to comply with this protocol and be available for the entire duration of the study.

In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory findings, and vital signs at screening and Day -1.

Disqualifiers

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease according to the Investigator.

History of any Gastrointestinal (GI) procedures (e.g., bariatric surgery) that could impair gastrointestinal absorption.

History of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the participant.

Clinically significant abnormalities on pre-study clinical examination or laboratory safety tests. Laboratory safety assessments (e.g., serum chemistry, hematology, coagulation) will be performed at screening and on Day -1 (if screening is prior to Day -1) to confirm eligibility.

Trial design

Treatments tested in this trial

  • QX-4533
  • Placebo

Treatment groups

90 Participants
are divided into 4 treatment groups

Sponsors and collaborators