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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-14

Study Completion Date

2019-05-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single intravenous doses of RC-01

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

Group Type ACTIVE_COMPARATOR

Single intravenous doses of RC-01

Intervention Type DRUG

Intravenous single escalating doses of RC-01

Single intravenous doses of placebo

Single intravenous doses of placebo to match RC-01

Group Type PLACEBO_COMPARATOR

Single intravenous doses of placebo

Intervention Type DRUG

Intravenous single doses of placebo to match RC-01

Multiple intravenous doses of RC-01

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

Group Type ACTIVE_COMPARATOR

Multiple intravenous doses of RC-01

Intervention Type DRUG

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

Multiple intravenous doses of placebo

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

Group Type PLACEBO_COMPARATOR

Multiple intravenous doses of placebo

Intervention Type DRUG

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

Interventions

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Single intravenous doses of RC-01

Intravenous single escalating doses of RC-01

Intervention Type DRUG

Single intravenous doses of placebo

Intravenous single doses of placebo to match RC-01

Intervention Type DRUG

Multiple intravenous doses of RC-01

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

Intervention Type DRUG

Multiple intravenous doses of placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes