An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects
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ClinicalTrials.gov Identifier: NCT02551549 |
Recruitment Status :
Completed
First Posted : September 16, 2015
Last Update Posted : June 26, 2017
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: CD101 IV Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Randomized, Double-Blind, Multiple-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects |
Study Start Date : | September 2015 |
Actual Primary Completion Date : | January 2016 |
Actual Study Completion Date : | January 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: CD101 IV
multiple ascending dose intravenous infusion
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Drug: CD101 IV
antifungal |
Placebo Comparator: Placebo
normal saline
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Drug: Placebo
Normal saline |
- Safety as assessed by the number of subjects with clinically significant adverse events [ Time Frame: Up to 2 weeks following last dose of study drug ]Number of subjects with clinically significant adverse events (AEs)
- Peak plasma concentration (Cmax) [ Time Frame: Up to 2 weeks following last dose of study drug ]
- Time to reach peak plasma concentration (Tmax) [ Time Frame: Up to 2 weeks following last dose of study drug ]
- Area under the concentration time curve (AUC) [ Time Frame: Up to 2 weeks following last dose of study drug ]
- The volume of plasma cleared of the drug per unit time (CL) [ Time Frame: Up to 2 weeks following last dose of study drug ]
- Apparent volume in which the drug is distributed (Vz) [ Time Frame: Up to 2 weeks following last dose of study drug ]
- The rate at which a drug is removed from the body (^z), [ Time Frame: Up to 2 weeks following last dose of study drug ]
- Terminal half-life (t1/2) [ Time Frame: Up to 2 weeks following last dose of study drug ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551549
United States, Arizona | |
Celerion Inc | |
Tempe, Arizona, United States, 85283 |
Principal Investigator: | Danielle Armas, MD | Celerion |
Responsible Party: | Cidara Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT02551549 |
Other Study ID Numbers: |
CD101.IV.1.02 |
First Posted: | September 16, 2015 Key Record Dates |
Last Update Posted: | June 26, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Subjects |