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

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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01870245
Enrollment
4
Registered
2013-06-06
Start date
2013-05-31
Completion date
Unknown
Last updated
2013-07-01

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

Conditions

Healthy Volunteer

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.

Interventions

Intravenous multiple dose

DRUGplacebo

Intravenous multiple dose

Sponsors

Achaogen, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Frequency of AEs28 days
Severity of AEs28 days

Secondary

MeasureTime frame
Plasma concentrations of ACHN-97516 days

Countries

United States

Outcome results

None listed

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