Study of the Safety, Tolerability, Pharmacokinetics and Pharmcodynamics of ILV-094 in Healthy Subjects

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetiks, and Pharmacodynamics of ILV-094 Administered Intravenously and One Dose of ILV-094 Administered Subcutaneously to Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00447681

Enrollment

Registered

2007-03-15

Start date

2006-12-31

Completion date

2007-11-30

Last updated

2007-12-13

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

Conditions

Healthy

Brief summary

This a randomized, double-blind placebo-controlled inpatient/outpatient, sequential group study of ascending single IV doses of ILV-094, an investigational drug, administered to healthy subjects. In addition, there will be one sub-cutaneous dose cohort, which will follow the 25 mg IV dose.

Interventions

DRUGILV-094

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy subjects (Men or women of nonchildbearing potential ), aged 18 to 50 years. * Body mass index in the range of 18 to 30 Kg/m2 and body weight greater than 50 Kg. * Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety, tolerability, pharmacokinetics and pharmcodynamics	—

Countries

United States

Outcome results

None listed

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