Safety and Pharmacokinetics of ELB353 in Healthy Men

A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Oral ELB353 in Healthy Male Volunteers - A Double-Blind, Randomized, Placebo-controlled, Sequential Group Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00977886

Enrollment

Registered

2009-09-16

Start date

2009-09-30

Completion date

2010-03-31

Last updated

2010-11-16

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

Conditions

Healthy Volunteers

Brief summary

The purpose of this trial is to study the safety and tolerability of repeated oral doses of ELB353, to evaluate the plasma levels of ELB353 and to study their effect on substances mediating inflammation.

Interventions

DRUGPlacebo

Oral, 10 days

DRUGELB353

Oral, 10 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy

Exclusion criteria

* Concomitant medication * Concomitant disease

Design outcomes

Primary

Measure	Time frame
Adverse event frequency and intensity	1 month

Secondary

Measure	Time frame
Plasma levels of ELB353	1 month
Inflammatory transmitter response ex vivo	2 weeks

Countries

Germany

Outcome results

None listed

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