NCT01042964: PR-15/01

An Open-Label, Dose-Escalating Safety and Pharmacokinetic Study of an Acute Intravenous Administration of PR-15, an Inhibitor of Platelet Adhesion, in Six Different Strengths in Healthy Male Volunteers

Completed Phase 1 Last updated 18 October 2012

What this trial tests

Phase 1 trial testing revacept (PR-15) in Thrombosis in 30 participants. Completed in 1 October 2007.

Timeline

1 March 2006

Primary endpoint
1 January 2007

1 October 2007

Quick facts

Lead sponsor	AdvanceCor GmbH
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 March 2006
Primary completion	1 January 2007
Estimated completion	1 October 2007
Sites	1 location across Germany

Drugs / interventions tested

• revacept (PR-15) — full drug profile →

Conditions studied

• Thrombosis — all drugs for Thrombosis →
• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
• Myocardial Infarction — all drugs for Myocardial Infarction →
• Stroke — all drugs for Stroke →

Sponsor

AdvanceCor GmbH — full company profile →

Who can join

Adults 18 to 45, male only, with Thrombosis or Acute Coronary Syndrome. Healthy volunteers can join.

What's being measured

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

• safety and tolerability adverse events (AEs), vital signs (BP/PR), 12 lead ECG, bleeding time, antibody titer and safety laboratory tests
  Time frame: 43 days

Sponsor's own description

Primary objective:

To evaluate safety and tolerability, adverse events (AEs), vital signs, ECG, bleeding time, evaluation of antibody titer and safety laboratory tests

Secondary objectives:

To evaluate the pharmacokinetics and pharmacodynamics (platelet aggregation)of six ascending single intravenous doses of PR-15 in healthy volunteers

Publications & conference data

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

1. Phase I and Phase II Therapies for Acute Ischemic Stroke: An Update on Currently Studied Drugs in Clinical Research.
   Reis C, Akyol O, Ho WM, Araujo C, et al · · 2017 · cited 31× · PMID 28286764 · DOI 10.1155/2017/4863079
2. Emerging Targets, Novel Directions, and Innovative Approaches in Thrombosis Therapy.
   Zhang W, Pei B, Zhou Y, Li H, et al · · 2025 · cited 1× · PMID 40153578 · DOI 10.14336/ad.2024.1688