A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 in Healthy Volunteers
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | May 2012 |
| Contact: | Duke Phase I Unit (queries regarding enrollment) |
| Email: | dcru-recruit@dm.duke.edu |
| Phone: | 919-613-6246 |
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
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.
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
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