R3R01 single dose study in healthy adults

Phase 1

Completed

• Conditions: Alport syndrome; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders; Focal Segmental Glomerulosclerosis; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12621001019897
• Lead Sponsor: River 3 Renal Corp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-04
• Study Completion: 2022-02-21
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

18 to 45 years of age
-A BMI between 18 to 32 kg/m2
-Participants of childbearing potential must agree use highly effective methods of contraception

Exclusion Criteria

-Participation in an investigational drug/device study within 3 months
- A history of clinically significant gastro-intestinal, cardiovascular, musculoskeletal, endocrine, hematological, psychiatric, renal, hepatic, broncho-pulmonary or neurological conditions, allergic disease or lipid metabolism disorders.
- A history of clinically significant drug hypersensitivity.
-A known history of porphyria, myopathy, or an active liver disease.
-Total bilirubin exceeding 1.5-fold upper limit of normal.
-clinically significant symptoms of an infectious illness within four weeks of dosing or a history of recurrent infections.
-Positive urine, breath or blood test for drugs of abuse and alcohol
- Positive for hepatitis B, hepatitis C, or HIV 1 and 2
- Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg and heart rate greater than 100 or less than 45 beats per minute.
-Personal or family history of congenital long QT syndrome.
- ECGs with QRS and/or T-wave judged by the investigator to be unfavorable
-Clinically significant abnormalities in laboratory test results
-Donation of blood over 450 mL within three months prior to screening.
- Smoker or non-smoker less than 6 months.
- Taking any drug or herbal medication that is an inhibitor or inducer of CYP450 within 4 weeks prior to the first dosing.
- Use of any prescription drug within 7 days of first dose of study drug
- Administration of live (attenuated) vaccines within 4 weeks before dosing

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma samples - To evaluate the Cmax, Tmax, t½, AUC0-24, AUClast, AUC truncated at 48 and 72 hrs(AUCt), CL/F and V/F of R3R01[PK samples will be taken pre-dose on Day 1 and at 2, 3, 6, 8, 10, 16 hours after dose. and once on the following days: 2, 3, 4, 5, 8, 15 and 84 post dose]

Secondary Outcome Measures

Name	Time	Method
Plasma samples - To evaluate the dose proportionality of R3R01 Cmax, Tmax, t½, AUC0-24, AUClast, AUC truncated at 48 and 72 hrs(AUCt), CL/F and V/F.[PK samples will be taken pre-dose on Day 1 and at 2, 3, 6, 8, 10, 16 hours after dose. and once on the following days: 2, 3, 4, 5, 8, 15 and 84 post dose,];To assess the safety and tolerability (review of occurrence of adverse events (by questioning of participants at each study visit), changes in physical examinations, vital signs (heart rate, temperature, blood pressure and respiratory rate), ECGs and clinical laboratory (hematology,biochemistry, urinalysis) parameters.) of a single dose of R3R01 [Adverse events reviewed continually until Day 84, post dose, throughout the study,<br>Physical exams: Day -1, Day 15. Day 84 post dose<br>Vital signs: Day -1, Day 1, Day 2,Day 3, Day 4, Day 5, Day 8, Day 15, Day 84 post dose<br>ECGs Day -1, Day 1, Day 2, Day 8, Day 15, Day 84 post dose<br>Laboratory samples Day -1, Day 2, Day 8, Day 15, Day 84 post dose<br><br>]