None listed
Conditions
Brief summary
This research project is being conducted to look at how safe and well tolerated a new drug called DUR-928 is when given as an intramuscular injection to subjects with chronic kidney disease when compared with healthy control subjects. The study will look at the study drugs effect when given as a single-dose injection at 2 different dose levels. The pharmacokinetics of DUR-928 will also be studied; this is done by measuring the amount of DUR-928 in the blood at different times throughout the dosing periods, allowing us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream). The pharmacodynamics will also be studied; this is done by measuring the amount of selected biomarkers in the blood and/or urine at different times throughout the dosing periods, allowing us to evaluate the effect of DUR-928 on the body.
Interventions
DUR-928 powder for constitution of intramuscular injection.
Each dose of DUR-928 is given as a single intramuscular injection into the gluteal muscle (buttock).
Each subject will receive a single dose of DUR-928 according to the cohort they are participating in.
The study will look at the effect of DUR-928 when given as a single dose at 3 different dose levels. All doses will be administered and supervised by study staff. The doses of the intervention are described below per cohort:
Cohort 1: 3
DUR-928 powder for constitution of intramuscular injection. Each dose of DUR-928 is given as a single intramuscular injection into the gluteal muscle (buttock). Each subject will receive a single dose of DUR-928 according to the cohort they are participating in. The study will look at the effect of DUR-928 when given as a single dose at 3 different dose levels. All doses will be administered and supervised by study staff. The doses of the intervention are described below per cohort: Cohort 1: 30mg DUR-928 (as an injection of 1mL) Cohort 2: 120mg DUR-928 (as an injection of 4mL) The solution used for constitution consists of 250 mg/mL hydroxypropyl betadex, NF (hydroxypropyl beta cyclodextrin), 0.276 mg/mL of sodium phosphate monobasic monohydrate, USP, and 1.136 mg/mL sodium phosphate dibasic anhydrous, USP, in sterile water for injection, USP. The final concentration of DUR-928 is 30 mg/mL. All doses will be administered and supervised by study staff. For each cohort, participants will be confined to the study unit for a total of 3 nights and 3 days, and have to attend the unit for additional 3 out-patient visits (including the screening visit). Study participants may take part in more than one cohort, as long as a washout period of at least 4 weeks is observed.
Sponsors
George Clinical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
All participants: Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed Female subjects must be of non-childbearing potential Willing and be able to be admitted to the clinical study unit for 3 nights and 3 days Able to abstain from alcohol and tobacco use during the study Patient with impaired kidney function: Impaired kidney function at screening, defined as Stage 3 kidney disease (eGFR between 30 and 59 ml/min/1.73m2) and stage 4 kidney disease (eGFR between 15 and 29 ml/min/1.73m2) Existing diagnosis of chronic kidney disease Matching healthy control subjects: Healthy as determined by medical history, physical examination, laboratory tests, ECG and vital signs in consideration of the individual’s age
Exclusion criteria
All participants: Females of child-bearing potential; pregnant or breastfeeding Significant blood loss, donated blood or received medication in another clinical trial 30 days prior to study participation Be immunocompromised (including history/seropositive of HIV) Be receiving any pharmacological treatment which might alter the absorption or metabolism of drugs Have a history of febrile illness 5 days prior to dosing Positive drug of abuse or alcohol breath test History of malignancy within 5 years before screening (except squamous and basal cell carcinomas of the skin and carcinomas of the cervix in situ, or a malignancy that in the opinion of the study physician and the medical monitor as cured with minimal risk of recurrence History of maintenance dialysis or kidney transplant History or presence of clinically concerning arrhythmias or prolongation of screening QT or QTc intervals Patient with impaired kidney disease: History of clinically significant comorbidity that increases the risk of adverse events Have any surgical or medical condition (other than impaired kidney disease) which might significantly alter the absorption or metabolism of drugs or which may jeopardies the subject during participation Presence of impaired liver function Clinical evidence of active liver disease, liver cirrhosis or severe ascites requiring intervention Symptoms or history of hepatic encephalopathy within 4 weeks of study entry Evidence of progressive kidney disease or unstable kidney function in the view of the investigator Matching healthy control subjects: Evidence of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurologic, or allergic disease (excluding well treated, asymptomatic seasonal allergies) Have any surgical or medical condition which might significantly alter the absorption or metabolism of drugs or which may jeopardies the subject during participation Presence of impaired liver function Clinical evidence of kidney disease or kidney injury
Outcome results
None listed