HealthyPhase 1NCT02516904
A Single Ascending 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 single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Oct 2015
- 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
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects
A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV
Read the detailed 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.
- 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 | single intravenous infusion ascending dose 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.
Number of subjects with clinically significant adverse events (AEs)
Measured: Up to 3 weeks
Secondary outcomes (1)
Pharmacokinetic Profile as measured by: maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the curve (AUC), clearance (CL), volume of distribution (Vz), elimination rate constant (^z), terminal half-life (t1/2)
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionOct 2015
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
- 32 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
- NCT02516904
- Sponsor's protocol ID
- CD101.IV.1.01
- Status last verified
- Jun 2017
- First submitted
- 31 Jul 2015
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02516904
- Acronym / sponsor ID
- CD101.IV.1.01
- Conditions
- Healthy
- Keywords
- Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Aug 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 single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV
Detailed 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.
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 IVsingle intravenous infusion ascending dose |
| 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)
- 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
Key exclusion criteria (6 listed)
- 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
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
Number of subjects with clinically significant adverse events (AEs)
Time frame: Up to 3 weeks
1 secondary outcome
Pharmacokinetic Profile as measured by: maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the curve (AUC), clearance (CL), volume of distribution (Vz), elimination rate constant (^z), terminal half-life (t1/2)
Time frame: Up to 3 weeks
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 22 May 2024.
- Individual participant dataSharing planned: No
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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 22 May 2024. 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?
Number of subjects with clinically significant adverse events (AEs) (time frame: Up to 3 weeks). 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 22 May 2024.