Safety and Tolerability of the First IV Dosing of SLV338 in Healthy Volunteers

A Placebo-Controlled, Combined Single and Multiple Rising Dose Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV338 After Intravenous Administration in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00885989

Enrollment

Registered

2009-04-22

Start date

2009-05-31

Completion date

2009-12-31

Last updated

2010-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

SLV338, phase I, healthy volunteers

Brief summary

This study will investigate the safety and tolerability of the first IV dosing of SLV338 in healthy volunteers.

Interventions

DRUGSLV338

5 - 1000 mg IV

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy

Exclusion criteria

* not healthy

Design outcomes

Primary

Measure	Time frame
Safety and tolerability parameters, including administration site tolerability, adverse events, clinical laboratory tests, vital signs and ECG	7 days

Secondary

Measure	Time frame
Pharmacokinetic parameters: AUC, Cmax, tmax, t½, λz, CL, CLR, Vz, Vss, MRT, Ae, and fe.	48 hours
Pharmacodynamic parameters: Plasma levels of ANP, cGMP, BNP, VIP, Big ET, ET-1, angiotensin II and aldosteron. Urinary volume and urine levels of cGMP, sodium, potassium, chloride, uric acid and creatinine, and creatinine clearance.	48 hours

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026