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CompletedNCT01597947Updated Jan 21, 2013

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 in Healthy Volunteers

A Phase 1 interventional study of ACHN-975 and placebo in Healthy Volunteer, sponsored by Achaogen, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-21.

Sponsored by Achaogen, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Achaogen, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key 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

Key Exclusion Criteria:

  • History of clinically significant disease
  • Pregnancy
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Arm A

    Drug: ACHN-975

  • Placebo comparator
    Arm B

    Drug: placebo

Interventions

  • DrugACHN-975

    Intravenous single dose

  • Drugplacebo

    Intravenous single dose

06

What researchers measure

Primary outcomes

  1. Frequency of AEs

    Time frame: 7 days

  2. Severity of AEs

    Time frame: 7 days

Secondary outcomes

  1. Plasma concentrations of ACHN-975

    Time frame: 2 days

  2. Urine concentrations of ACHN-975

    Time frame: 2 days

07

Study locations

1 site
  • Investigational Site
    Durham, North Carolina 27705, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01597947
Lead sponsor
Achaogen, Inc.
Collaborators
Defense Medical Research and Development Program
Responsible party
Sponsor
First posted
May 15, 2012
Start date
May 2012
Completion
Dec 2012
Last update
Jan 21, 2013

Study contacts

Medical Director
study director · Achaogen, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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