An Ascending Multiple 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

NCT02551549

CD101.IV.1.02

Details and patient eligibility

About

A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 Injection in Healthy Subjects.

Full description

This is a Phase 1, single-center, prospective, randomized, double-blind study of multiple ascending doses (MAD) of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 3 cohorts of 8 subjects each will be randomized to receive multiple IV doses of CD101 Injection or placebo infusions. Dose levels of CD101 Injection to be assessed will follow an ascending multiple-dose regimen.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men must be surgically sterilized or using contraception,
• No significant findings on physical exam, ECG, clinical laboratory tests,
• Body mass index (BMI) between 18.5 and 32.0 kg/m2, inclusive
• Must provide written informed consent

Exclusion criteria

• Females of child bearing potential
• Signs and or symptoms of acute illness or chronic disease
• 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

---

24 participants in 2 patient groups, including a placebo group

CD101 IV

Experimental group

Description:

multiple ascending dose intravenous infusion

Treatment:

Drug: CD101 IV

Placebo

Placebo Comparator group

Description:

normal saline

Treatment:

Drug: Placebo