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

NCT03832517 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-05-29

No results posted yet for this study

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

Interventions

DRUG

Single intravenous doses of RC-01

Intravenous single escalating doses of RC-01

DRUG

Single intravenous doses of placebo

Intravenous single doses of placebo to match RC-01

DRUG

Multiple intravenous doses of RC-01

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

DRUG

Multiple intravenous doses of placebo

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

Sponsors & Collaborators

  • Recida Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-14
Primary Completion
2019-04-22
Completion
2019-05-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03832517 on ClinicalTrials.gov