A Single and Multiple Ascending Dose Escalation and Food Effect Study of QX-4533 in Healthy Participants
ConditionHealthy
Trial statusRecruiting
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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
QX-4533
DrugQX-4533 tablets
Placebo
DrugQX-4533 matched-placebo tablets
Treatment groups
90 Participants
are divided into 4 treatment groupsGroup A: Part 1: Single Ascending Dose (SAD)Experimental treatment 2 interventions
Group B: Part 2: Multiple Ascending Dose (MAD)Experimental treatment 2 interventions
Group C: Part 3: Food Effect - Sequence 1: ABExperimental treatment 1 intervention
Group D: Part 3: Food Effect - Sequence 2: BAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame
From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])2
Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Time frame
From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])Secondary outcomes
1
Maximum Observed Plasma Concentration (Cmax)
Time frame
Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)2
Time of the Maximum Measured Concentration (Tmax)
Time frame
Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)3
Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable concentration-time point (AUClast)
Time frame
Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)4
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf)
Time frame
Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov