A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Ranging Study in Healthy Volunteers to Assess Safety, Tolerability, and Evaluate the Pharmacokinetics and Pharmacodynamics of R2R01

Completed

Conditions: Kidney failure
10038430

Registration Number: NL-OMON51081

Lead Sponsor: River 2 Renal Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 64

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

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the tolerability and safety of ascending single and multiple doses<br /><br>of R2R01 in healthy volunteers.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine the pharmacokinetic (PK) parameters of R2R01.<br /><br>- To compare the PK of a single 4-mg subcutaneous (SC) dose with a single 4-mg<br /><br>intravenous (IV) dose.<br /><br>- To establish a dose concentration-response relationship for tolerability and<br /><br>pharmacodynamic (PD) parameters over a range of R2R01 doses in order to select<br /><br>a dose to be studied in patients after single and multiple dose administrations<br /><br>have been completed in healthy volunteers.<br /><br>- To assess the potential immunogenicity of R2R01 after multiple dose<br /><br>administrations in healthy volunteers.</p><br>