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NCT01702649 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects

A Phase 1 study of Healthy Volunteers and Bacterial Infections, sponsored by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company).

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT01702649: Completed Phase 1 study of Healthy Volunteers and Bacterial Infections, sponsored by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company).

NCT01702649 is a Phase 1 study of Healthy Volunteers and Bacterial Infections that has completed, run by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company). The registered enrollment target is 36 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01702649, a Phase 1 study of Healthy Volunteers and Bacterial Infections, has completed, sponsored by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company).

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
1
Study location

Study Summary

RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor to treat bacterial infections, including those due to multi-drug resistant bacteria.

Primary Outcome

Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.

Interventions

  • DRUG Placebo
  • DRUG RPX2003 (Biapenem)

Study Locations (1)

Arizona

  • Celerion - Tempe

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2012-08
Est. Completion 2012-11
Phase Phase 1

What the finished NCT01702649 record still lists

NCT01702649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower).

The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01702649 reports a single indexed study location in Arizona.

Frequently Asked Questions

What is clinical trial NCT01702649 about?

NCT01702649 is a clinical study titled "Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects". RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor to treat bacterial infections, including those due to multi-drug resistant bacteria.

What is the current status of trial NCT01702649?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-08. Estimated completion is 2012-11.

What conditions does trial NCT01702649 study?

This clinical trial studies the following conditions: Healthy Volunteers, Bacterial Infections.

What interventions are being tested in trial NCT01702649?

The interventions under investigation include: Placebo (DRUG), RPX2003 (Biapenem) (DRUG).

Who is sponsoring clinical trial NCT01702649?

This trial is sponsored by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company), which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01702649 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy Volunteers

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01702649's enrollment target sits among peer trials

36 166th of 283 higher than 115 of 283 other Healthy Volunteers trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01702649, the US trial registry maintained by the National Library of Medicine. NCT01702649 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.