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

Achaogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: placebo; Drug: ACHN-975

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01597947

ACHN-975-001

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Arm A

Experimental group

Treatment:

Drug: ACHN-975

Arm B

Placebo Comparator group

Treatment:

Drug: placebo