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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01597947

Enrollment

Registered

2012-05-15

Start date

2012-05-31

Completion date

2012-12-31

Last updated

2013-01-21

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 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.

Interventions

DRUGACHN-975

Intravenous single dose

DRUGplacebo

Intravenous single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 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

Measure	Time frame
Frequency of AEs	7 days
Severity of AEs	7 days

Secondary

Measure	Time frame
Plasma concentrations of ACHN-975	2 days
Urine concentrations of ACHN-975	2 days

Countries

United States

Outcome results

None listed

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