NCT01702649 is a Phase 1 clinical trial of RPX2003 (Biapenem) in Healthy Volunteers, sponsored by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company).

What drugs are being tested in NCT01702649?

Interventions in NCT01702649: RPX2003 (Biapenem), Placebo.

What condition does NCT01702649 study?

NCT01702649 studies Healthy Volunteers, Bacterial Infections.

Is NCT01702649 still recruiting?

NCT01702649 is currently completed. Last updated 29 November 2012.

Last reviewed 2012-11-29 · How we verify

NCT01702649

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 in Healthy Adult Subjects

Completed Phase 1 Last updated 29 November 2012

What this trial tests

Phase 1 trial testing RPX2003 (Biapenem) in Healthy Volunteers in 36 participants. Completed in 1 November 2012.

Timeline

1 August 2012

Primary endpoint
1 November 2012

1 November 2012

Quick facts

Lead sponsor	Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	36
Start date	1 August 2012
Primary completion	1 November 2012
Estimated completion	1 November 2012
Sites	1 location across United States

Drugs / interventions tested

RPX2003 (Biapenem) — full drug profile →
Placebo

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →
Bacterial Infections — all drugs for Bacterial Infections →

Sponsor

Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers or Bacterial Infections. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety from baseline through the end of the study.
Time frame: Study Day 1 to 13.
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.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Innovative Strategies in Drug Repurposing to Tackle Intracellular Bacterial Pathogens.
Lorente-Torres B, Llano-Verdeja J, Castañera P, Ferrero HÁ, et al · · 2024 · cited 6× · PMID 39335008 · DOI 10.3390/antibiotics13090834
A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Biapenem in Healthy Adult Subjects.
Griffith DC, Morgan EE, Dudley MN, Loutit JS. · · 2023 · cited 6× · PMID 33685898 · DOI 10.1128/aac.02612-20
Small-molecule inhibitors of bacterial-producing metallo-β-lactamases: insights into their resistance mechanisms and biochemical analyses of their activities.
Ayipo YO, Chong CF, Mordi MN. · · 2023 · cited 4× · PMID 37360393 · DOI 10.1039/d3md00036b

Verify or expand the search:

Other recruiting trials for Healthy Volunteers

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01702649 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Last refreshed: 29 November 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01702649.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing