Single and Multiple Dose Escalation Trial of an Intravenous Antibiotic RC-01

NCT03832517 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: RC-01-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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)

  Up to the final follow-up 1 day visit

Secondary Outcomes (3)

• Plasma concentration time data for RC-01 and metabolites

  Pre-dose through 24 hours after the final infusion of study drug

• Bioavailability of RC-01 and other RC-01 metabolites

  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

  Pre-dose through 24 hours after the final infusion of study drug

Study Arms (4)

Single intravenous doses of RC-01

ACTIVE COMPARATOR

Single escalating doses of RC-01 from 200 mg to 1600 mg

Drug: Single intravenous doses of RC-01

Single intravenous doses of placebo

PLACEBO COMPARATOR

Single intravenous doses of placebo to match RC-01

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

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

Drug: Multiple intravenous doses of placebo

Interventions

Single intravenous doses of RC-01 DRUG

Intravenous single escalating doses of RC-01

Single intravenous doses of RC-01

Single intravenous doses of placebo DRUG

Intravenous single doses of placebo to match RC-01

Single intravenous doses of placebo

Multiple intravenous doses of RC-01 DRUG

Multiple ascending doses of RC-01 given intravenously two or three times daily for 10 days

Multiple intravenous doses of RC-01

Multiple intravenous doses of placebo DRUG

Multiple doses of placebo to match RC-01 given intravenously two or three times daily for 10 days

Multiple intravenous doses of placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Recida Therapeutics, Inc.: lead

Study Sites (1)

Celerion

Phoenix, Arizona, 85283, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 6, 2019
• Study Start: April 14, 2019
• Primary Completion: April 22, 2019
• Study Completion: May 8, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)