Kidney failure
Conditions
Interventions
Part A
Groups A1, A3, A4, A5
Subjects will be given R2R01 or placebo once as an injection under the skin
(subcutaneous).
Group A2
Subjects will be given R2R01 or placebo once as an injection under
Sponsors
River 2 Renal Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Sex: male or female; for the SAD part and the first cohort in the MAD part, females must be of nonchildbearing potential, or postmenopausal. Women of childbearing potential will be excluded from all cohorts in the SAD part and from the first MAD cohort for reasons outlined in Section 3.2.4 of the protocol. If no ADAs are observed in the first MAD cohort (5.0 mg), inclusion of WOCBP may be permitted in subsequent MAD cohorts. 2. Age: 18 to 55 years, inclusive, at screening. 3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening. 4. Weight: 50 to 110 kg, inclusive, at screening. 5. Status: healthy subjects.
Exclusion criteria
Exclusion criteria: 1. Previous participation in the current study. 2. Employee of PRA or the Sponsor. 3. History of a serious adverse reaction or significant hypersensitivity to any drug, has a known clinically significant allergy to anti-inflammatory drugs or chemically related compounds or has a clinically significant allergy to drugs, foods or other materials (in the opinion of the Investigator). 4. Using tobacco products within 3 months prior to (the first) drug administration. 5. History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the tolerability and safety of ascending single and multiple doses of R2R01 in healthy volunteers. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determine the pharmacokinetic (PK) parameters of R2R01. - To compare the PK of a single 4-mg subcutaneous (SC) dose with a single 4-mg intravenous (IV) dose. - To establish a dose concentration-response relationship for tolerability and pharmacodynamic (PD) parameters over a range of R2R01 doses in order to select a dose to be studied in patients after single and multiple dose administrations have been completed in healthy volunteers. - To assess the potential immunogenicity of R2R01 after multiple dose administrations in healthy volunteers. | — |
Countries
Netherlands
Outcome results
None listed