Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses

Ascending Multiple 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

NCT00909688

Enrollment

Registered

2009-05-28

Start date

2009-06-05

Completion date

2009-07-24

Last updated

2018-09-27

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

Conditions

Healthy

Keywords

Healthy Subjects

Brief summary

To determine the safety, tolerability, and drug absorption profile of multiple IV doses of BLI 489 in healthy subjects.

Interventions

DRUGBLI-489

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Men or women of non-childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening; * Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg.; * Healthy as determined by the investigator on the basis of screening evaluations; * Calculated creatinine clearance within normal limits using the Cockcroft-Gault formula; * Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history, and if a smoker must be able to abstain from smoking during the inpatient stay; * Have a high probability for compliance with and completion of the study.

Exclusion criteria

* Presence or history of any disorder that may prevent the successful completion of the study; * Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease; * Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the investigational product; * Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1; * History of drug abuse within 1 year before study day 1; * Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.

Design outcomes

Primary

Measure	Time frame
Assess safety of drug given to healthy subjects by evaluating any reported adverse events (AEs), scheduled physical examinations, vital sign measurements, 12-lead ECGs, and clinical laboratory test results.	4 months

Countries

United States

Outcome results

None listed

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