SafetyPhase 1NCT03832517
Single and Multiple Dose Escalation Trial of an Intravenous Antibiotic RC-01
A Phase 1 study testing Single intravenous doses of RC-01 and Multiple intravenous doses of RC-01 in people with Safety, run by Recida Therapeutics, Inc. at 1 site in United States.
Trial summary
A Phase 1 study of the safety, tolerability and pharmacokinetics of a new antibiotic (RC-01). In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of RC-01. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- Single intravenous doses of RC-01 and Multiple intravenous doses of RC-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2019to 8 May 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments
- Willing and able to provide written informed consent
Who cannot join
- Underlying hepatic, renal, metabolic, cardiovascular or immunologic disorders
- Unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements
- Women who are pregnant and/or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RC-01 for Injection in Healthy Adult Subjects
A Phase 1 study of the safety, tolerability and pharmacokinetics of a new antibiotic (RC-01). In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of RC-01. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of RC-01 given either twice daily or three times daily.
- Conditions
- Safety
- Being tested
- Single intravenous doses of RC-01, Single intravenous doses of placebo, Multiple intravenous doses of RC-01, Multiple intravenous doses of placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single intravenous doses of RC-01Drug
Intravenous single escalating doses of RC-01
Single intravenous doses of placeboDrug
Intravenous single doses of placebo to match RC-01
Multiple intravenous doses of RC-01Drug
Multiple ascending doses of RC-01 given intravenously two or three times daily for 10 days
Multiple intravenous doses of placeboDrug
Multiple doses of placebo to match RC-01 given intravenously two or three times daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Single intravenous doses of RC-01 | Active comparator | Single escalating doses of RC-01 from 200 mg to 1600 mg Receives: Drug: Single intravenous doses of RC-01 |
| Single intravenous doses of placebo | Placebo comparator | Single intravenous doses of placebo to match RC-01 Receives: Drug: Single intravenous doses of placebo |
| Multiple intravenous doses of RC-01 | Active comparator | Two or three times daily escalating intravenous doses of RC-01 for 10 days. Doses to be determined Receives: Drug: Multiple intravenous doses of RC-01 |
| Multiple intravenous doses of placebo | Placebo comparator | Two or three times daily intravenous doses of placebo to match RC-01 Receives: Drug: Multiple intravenous doses of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a treatment-related adverse event collected over the duration of the study
Safety assessments will include physical examinations, vital signs including heart rate and respiratory rate, clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis), and ECG parameters (including P-wave onset, QRS onset, QRS offset, and end of T wave)
Measured: Up to the final follow-up 1 day visit
Secondary outcomes (3)
Plasma concentration time data for RC-01 and metabolites
Individual and mean plasma concentration time data for RC-01 and its metabolites
Measured: Pre-dose through 24 hours after the final infusion of study drug
Bioavailability of RC-01 and other RC-01 metabolites
Levels of RC-01 and metabolites in blood
Measured: Pre-dose through 24 hours after the final infusion of study drug
Elimination of RC-01 and its metabolites in the urine following single and multiple dose administration
Levels of RC-01 and its metabolites in the urine
Measured: Pre-dose through 24 hours after the final infusion 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 posted6 Feb 2019
- Study start14 Apr 2019
- Primary completion22 Apr 2019
- Study completion8 May 2019
Why it stopped: safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recida Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832517
- Sponsor's protocol ID
- RC-01-001
- Status last verified
- May 2019
- First submitted
- 31 Jan 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RC-01 for Injection in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03832517
- Acronym / sponsor ID
- RC-01-001
- Conditions
- Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: safety
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Recida Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2019 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 6 Feb 2019 (actual)
- 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 Phase 1 study of the safety, tolerability and pharmacokinetics of a new antibiotic (RC-01). In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of RC-01. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of RC-01 given either twice daily or three times daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single intravenous doses of RC-01 | Active comparator | Drug: Single intravenous doses of RC-01Single escalating doses of RC-01 from 200 mg to 1600 mg |
| Single intravenous doses of placebo | Placebo comparator | Drug: Single intravenous doses of placeboSingle intravenous doses of placebo to match RC-01 |
| Multiple intravenous doses of RC-01 | Active comparator | Drug: Multiple intravenous doses of RC-01Two or three times daily escalating intravenous doses of RC-01 for 10 days. Doses to be determined |
| Multiple intravenous doses of placebo | Placebo comparator | Drug: Multiple intravenous doses of placeboTwo or three times daily intravenous doses of placebo to match RC-01 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects
- Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments
- Willing and able to provide written informed consent
Key exclusion criteria (3 listed)
- Underlying hepatic, renal, metabolic, cardiovascular or immunologic disorders
- Unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements
- Women who are pregnant and/or nursing
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 |
|---|---|---|
| Single intravenous doses of RC-01Intravenous single escalating doses of RC-01 | Drug | Single intravenous doses of RC-01 |
| Single intravenous doses of placeboIntravenous single doses of placebo to match RC-01 | Drug | Single intravenous doses of placebo |
| Multiple intravenous doses of RC-01Multiple ascending doses of RC-01 given intravenously two or three times daily for 10 days | Drug | Multiple intravenous doses of RC-01 |
| Multiple intravenous doses of placeboMultiple doses of placebo to match RC-01 given intravenously two or three times daily for 10 days | Drug | Multiple intravenous doses of placebo |
Primary outcome
Number of participants with a treatment-related adverse event collected over the duration of the study
Time frame: Up to the final follow-up 1 day visit
Safety assessments will include physical examinations, vital signs including heart rate and respiratory rate, clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis), and ECG parameters (including P-wave onset, QRS onset, QRS offset, and end of T wave)
3 secondary outcomes
Plasma concentration time data for RC-01 and metabolites
Time frame: Pre-dose through 24 hours after the final infusion of study drug
Bioavailability of RC-01 and other RC-01 metabolites
Time frame: Pre-dose through 24 hours after the final infusion of study drug
Elimination of RC-01 and its metabolites in the urine following single and multiple dose administration
Time frame: Pre-dose through 24 hours after the final infusion of study drug
Results and safety
The study was stopped early (reason given: safety). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Single intravenous doses of RC-01 and Multiple intravenous doses of RC-01 in people with Safety, run by Recida Therapeutics, Inc. 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 May 2019. 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 was stopped early (reason given: safety). Results are not available in the source record.
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 participants with a treatment-related adverse event collected over the duration of the study (time frame: Up to the final follow-up 1 day visit). 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 29 May 2019.