Study Evaluating Single Doses of BLI-489 in Healthy Subjects

Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00820404

Enrollment

Registered

2009-01-12

Start date

2009-01-31

Completion date

2009-04-30

Last updated

2009-07-17

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

Conditions

Healthy Subjects

Brief summary

The purpose of this study is to evaluate the safety, and tolerability of single doses of BLI-489 administered intravenously in healthy subjects, and also how the drug is absorbed and eliminated.

Interventions

DRUGBLI-489

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. Men or women of nonchildbearing potential, 18 to 50 years of age inclusive at screening. 2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg. 3. Healthy as determined by the investigator on the basis of the screening evaluations. 4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion criteria

1. Presence of history of any disorder that may prevent the successful completion of the study. 2. History of drug abuse within 1 year.

Design outcomes

Primary

Measure	Time frame
Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities.	15 days

Secondary

Measure	Time frame
Pharmacokinetics as evaluated by drug concentrations in the blood and urine.	4 days

Countries

United States

Outcome results

None listed

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