A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 in Healthy Volunteers
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) ACHN-975 in Normal Healthy Volunteers
1 other identifier
interventional
50
1 country
1
Brief Summary
This is a double-blind, randomized, placebo-controlled, single ascending dose study to assess the safety, tolerability, and PK of ACHN-975 in normal healthy volunteers. This study will take place in the US at one clinical site.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 8, 2012
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 21, 2013
January 1, 2013
May 8, 2012
January 18, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Frequency of AEs
7 days
Severity of AEs
7 days
Secondary Outcomes (2)
Plasma concentrations of ACHN-975
2 days
Urine concentrations of ACHN-975
2 days
Study Arms (2)
Arm A
EXPERIMENTALArm B
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Body weight between 40 and 100 kilograms (between \~88 pounds and \~220 pounds)
- Use of contraception
- Stable health
- Negative tests for alcohol, tobacco, and drugs of abuse
You may not qualify if:
- History of clinically significant disease
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Achaogen, Inc.lead
- Defense Medical Research and Development Programcollaborator
Study Sites (1)
Investigational Site
Durham, North Carolina, 27705, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Director
Achaogen, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2012
First Posted
May 15, 2012
Study Start
May 1, 2012
Study Completion
December 1, 2012
Last Updated
January 21, 2013
Record last verified: 2013-01