HealthyPhase 1NCT02551549
An Ascending Multiple Dose Study of CD101 IV in Healthy Subjects
A Phase 1 study testing CD101 IV in people with Healthy, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 Injection in Healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CD101 IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 Injection in Healthy Subjects.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- CD101 IV, Placebo
- Keywords
- Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD101 IVDrug
antifungal
PlaceboDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| CD101 IV | Experimental | multiple ascending dose intravenous infusion Receives: Drug: CD101 IV |
| Placebo | Placebo comparator | normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by the number of subjects with clinically significant adverse events
Number of subjects with clinically significant adverse events (AEs)
Measured: Up to 2 weeks following last dose of study drug
Secondary outcomes (7)
Peak plasma concentration (Cmax)
Measured: Up to 2 weeks following last dose of study drug
Time to reach peak plasma concentration (Tmax)
Measured: Up to 2 weeks following last dose of study drug
Area under the concentration time curve (AUC)
Measured: Up to 2 weeks following last dose of study drug
The volume of plasma cleared of the drug per unit time (CL)
Measured: Up to 2 weeks following last dose of study drug
Apparent volume in which the drug is distributed (Vz)
Measured: Up to 2 weeks following last dose of study drug
The rate at which a drug is removed from the body (^z),
Measured: Up to 2 weeks following last dose of study drug
Terminal half-life (t1/2)
Measured: Up to 2 weeks following last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danielle Armas, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551549
- Sponsor's protocol ID
- CD101.IV.1.02
- Status last verified
- Jun 2017
- First submitted
- 14 Sep 2015
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02551549
- Acronym / sponsor ID
- CD101.IV.1.02
- Conditions
- Healthy
- Keywords
- Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 Injection in Healthy Subjects.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD101 IV | Experimental | Drug: CD101 IVmultiple ascending dose intravenous infusion |
| Placebo | Placebo comparator | Drug: Placebonormal saline |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD101 IVantifungal | Drug | CD101 IV |
| PlaceboNormal saline | Drug | Placebo |
Primary outcome
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)
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Armas, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD101 IV in people with Healthy, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.