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Clinical Trials/NCT01870245
NCT01870245
Terminated
Phase 1

A Phase 1 Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 Administered Intravenously to Healthy Volunteers

Achaogen, Inc.1 site in 1 country4 target enrollmentMay 2013
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ConditionsHealthy Volunteer
InterventionsACHN-975placebo
DrugsACHN-975placebo

Overview

Phase
Phase 1
Intervention
ACHN-975
Conditions
Healthy Volunteer
Sponsor
Achaogen, Inc.
Enrollment
4
Locations
1
Primary Endpoint
Frequency of AEs
Status
Terminated
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled, multiple-dose study, designed to assess the safety, tolerability, and pharmacokinetics (PK) of ACHN-975. This study will take place in the US at one clinical site.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
June 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •History of clinically significant disease
  • •Pregnancy

Arms & Interventions

ACHN-975

Intervention: ACHN-975

Placebo

Intervention: placebo

Outcomes

Primary Outcomes

Frequency of AEs

Time Frame: 28 days

Severity of AEs

Time Frame: 28 days

Secondary Outcomes

  • Plasma concentrations of ACHN-975(16 days)

Study Sites (1)

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