A Single Ascending Dose Study of CD101 IV in Healthy Subjects

Cidara Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: CD101 IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02516904

CD101.IV.1.01

Details and patient eligibility

About

A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV

Full description

This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 4 cohorts of 8 subjects, each will be randomized to receive single IV doses of CD101 Injection or placebo. Dose levels of CD101 to be assessed will follow an ascending single-dose regimen.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males surgically sterilized or using contraception,
• No significant findings on physical, ECG, clinical laboratory tests,
• BMI between 18.5 - 32.0,
• Must provide informed consent

Exclusion criteria

• Females of child bearing potential,
• Signs and or symptoms of an acute or chronic illness,
• Use of prescription medications within 28 days,
• Use of OTC, supplements, and herbals within 14 days,
• Current smoker
• Previous participation in a clinical study within 28 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

CD101 IV

Experimental group

Description:

single intravenous infusion ascending dose

Treatment:

Drug: CD101 IV

Placebo

Placebo Comparator group

Description:

normal saline

Treatment:

Drug: Placebo