None listed
Conditions
Brief summary
This project is testing the safety and pharmacokinetics of single and multiple oral doses of a new drug called GBP-088. GBP-088 is being developed for the treatment of recurrent kidney stones. You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. In Part 1, participants will be randomised (assigned randomly, like flipping a coin) to receive single oral dose(s) of either the active study drug or placebo. In Part 2, participants will be randomised (assigned randomly, like flipping a coin) to receive multiple oral dose(s) of either the active study drug or placebo. It is hoped that this research will help determine the safety of GBP-088 when given to healthy men or women so that it can be tested in patients with recurrent kidney stone disease
Interventions
Approximately 64 healthy men or women will be enrolled in this study. There will be two parts to the study.
In the first part of the study approximately 40 healthy men and women will be enrolled in up to 5 single ascending dose cohorts comprising 8 subjects each. Participants within each cohort will be randomised to receive a single dose of either oral GBP-088 (6 subjects) or oral placebo (2 subjects). All cohorts will be started with sentinel dosing. All doses will be administered under direct
Approximately 64 healthy men or women will be enrolled in this study. There will be two parts to the study. In the first part of the study approximately 40 healthy men and women will be enrolled in up to 5 single ascending dose cohorts comprising 8 subjects each. Participants within each cohort will be randomised to receive a single dose of either oral GBP-088 (6 subjects) or oral placebo (2 subjects). All cohorts will be started with sentinel dosing. All doses will be administered under direct observation in the Phase 1 unit. The doses for each cohort are shown below. Cohort SC-1: 100mg Cohort SC-2: 300mg Cohort SC-3: 600mg Cohort SC-4: 1200mg Cohort SC-5: 2000mg A maximum of 24 additional participants in optional cohorts or cohort expansions may be considered for the first part of the study if supported by available PK and safety data and approved by the Safety Review Committee. Optional cohorts or cohort expansions will be assessed after the completion of SC-5. In the second part of the study approximately 24 healthy men and women will be enrolled into up to 3 multiple ascending dose cohorts comprising 8 subjects each. Participants within each cohort will be randomised to receive multiple doses of either oral GBP-088 (6 subjects) or oral placebo (2 subjects). Each dose regimen will be administered twice a day for 6 days with a single dose administered on the morning of Day 7 for a total of 13 total doses. All doses will be administered under direct observation in the Phase 1 unit. The second part of the study will not occur until at least after completion of SC-4 in the first part of the study. The dose selection and dosing regimen for the second part of the study will be confirmed based upon the data from the first part of the study. Cohort MC-1: 400mg twice a day for 6 days and a single dose on Day 7 (13 doses) Cohort MC-2: 600mg twice a day for 6 days and a single dose on Day 7 (13 doses) Cohort MC-3: 1000mg twice a day for 6 days and a single dose on Day 7 (13 doses) A maximum of 16 additional participants in optional cohorts or cohort expansions may be considered for the second part of the study if supported by available PK and safety data and approved by the Safety Review Committee. Optional cohorts or cohort expansions will be assessed after the completion of MC-3.
Sponsors
GondolaBio Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Deemed healthy as determined by medical history, physical examination, vital sign measurements, ECG, and laboratory safety tests Not lactating or pregnant Body weight at least 50kg (male) and 45kg (female) and body mass index within the range 18-32 kg/m2 (inclusive) Capable of giving signed informed consent Agrees to be available for all study visits and cooperates fully with the requirements of the study protocol, including the schedule of assessments
Exclusion criteria
Past or current history of moderate or severe psychiatric illness Past or current history of mild, moderate, or severe substance abuse Past or current history of alcohol use disorder History of acute illness, infectious condition or chronic disease within 14 days before Screening Any history of cardiovascular, cerebrovascular, or peripheral vascular disease Use or intended use of prohibitied medications Received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) before Screening Positive alcohol breath test or urine test for drugs of abuse Positive serology panel Clinically significant vital signs Clinically significant laboratory abnormalities Clinically significant history or presence of ECG findings
Outcome results
None listed