A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBugworks Research Inc.
About this trial
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: Healthy male or female 18 to 55 years of age, inclusive, at time of consent
Body mass index (BMI): BMI ≥ 19.0 and ≤ 30.0 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive)
Health Status: Medically healthy without significant history of any chronic diseases or conditions (such as cardiovascular, renal, hepatic, neurological, hematological, gastrointestinal, endocrine, or musculoskeletal disorders). Volunteers must have no clinically significant abnormalities in medical history, as determined by the Investigator.
No findings in Physical examination or vital signs (including temperature, heart rate, respiratory rate, and blood pressure) that the Investigator determines would interfere with interpretation of study results
Disqualifiers
1) Pregnancy and Lactation: Women who are pregnant and/or lactating. 2) Significant Medical History: History or presence of significant cardiovascular (including QT prolongation, clinically significant hypokalemia, or other proarrhythmic conditions), pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine (including glucose intolerance, diabetes mellitus), immunologic (including asthma or seasonal allergies [that require intermittent use of steroids or other medication]), musculoskeletal (including tendinopathy), dermatologic, or neurological disease (including seizure disorders, psychiatric disorders), including any acute illness or surgery within the past 3 months, as determined by the Investigator to be clinically relevant.
History of any kidney disease or current or chronic history of impaired renal function as indicated by a calculated creatinine clearance (Cockcroft-Gault formula) <80 milliliter per minute (mL/min).
Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert syndrome or asymptomatic gallstones) 3) Laboratory abnormalities
Trial design
Design model
Sequential
Treatments tested in this trial
BWC0977
DrugSAD Cohorts: Double-blind dosing will occur. Six participants will receive single doses of BWC0977. The dose escalation steps may be altered following review of the safety data upon completion of each cohort. MAD Cohorts: Double blind dosing will occur. Six participants in each cohort will receive multiple doses of BWC0977. The dose escalation steps may be altered following review of the safety data upon completion of each cohort. Dosing will commence on the morning of Day 1. Dosing frequency to be confirmed based on safety, tolerability, and PK data from SAD and previous MAD cohorts. Daily dosing will continue for a total of 7-10 consecutive days (as per schedule).
Placebo
DrugSAD Cohorts: Two participants in each cohort will receive a matching placebo. MAD Cohorts: Two participants in each cohort will receive a matching placebo.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: BWC0977Experimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of treatment-emergent adverse events (TEAEs and serious adverse events (SAEs) overall and by intensity (Safety and tolerability).
Description: This outcome combines the measure of the number of participants experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatment.
Time frame
SAD: Up to 8 days MAD: Up to 16 daysSecondary outcomes
1
AUC[0-t] of BWC0977 following single dose administration
Area under the plasma concentration curve from time zero to last time of quantifiable concentration (AUC0-t) of BWC0977 following single dose administration
Time frame
Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.2
AUC[0-inf] of BWC0977 following single dose administration
Area under the plasma concentration curve from time zero to infinity (AUC0-inf) of BWC0977 following single dose administration
Time frame
Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.3
AUC[0-8], AUC[0-12], AUC[0-24] of BWC0977 following single dose administration
AUC from time zero to 8, 12, and 24 hours (AUC\[0-8\], AUC\[0-12\], AUC\[0-24\]) of BWC0977 following single dose administration
Time frame
Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.4
Cmax of BWC0977 following single dose administration
Maximum observed plasma concentration (Cmax) of BWC0977 following single dose administration
Time frame
Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bugworks Research Inc.
Lead sponsor
Nucleus Network Ltd
Collaborator
Source ClinicalTrials.gov