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

Recida Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Safety

Treatments: Drug: Single intravenous doses of placebo; Drug: Multiple intravenous doses of RC-01; Drug: Multiple intravenous doses of placebo; Drug: Single intravenous doses of RC-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT03832517

RC-01-001

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 4 patient groups, including a placebo group

Single intravenous doses of RC-01

Active Comparator group

Description:

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

Treatment:

Drug: Single intravenous doses of RC-01

Single intravenous doses of placebo

Placebo Comparator group

Description:

Single intravenous doses of placebo to match RC-01

Treatment:

Drug: Single intravenous doses of placebo

Multiple intravenous doses of RC-01

Active Comparator group

Description:

Two or three times daily escalating intravenous doses of RC-01 for 10 days. Doses to be determined

Treatment:

Drug: Multiple intravenous doses of RC-01

Multiple intravenous doses of placebo

Placebo Comparator group

Description:

Two or three times daily intravenous doses of placebo to match RC-01

Treatment:

Drug: Multiple intravenous doses of placebo