Safety and Pharmacokinetics of ELB353 in Healthy Men

Biotie Therapies

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ELB353; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00977886

BTT70-CD018

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy

Exclusion criteria

• Concomitant medication
• Concomitant disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

ELB353

Experimental group

Treatment:

Drug: ELB353