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First in Human Study of ANXV (Recombinant Human Annexin A5) in Healthy Volunteers

NCT04850339 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-05-16

No results posted yet for this study

Summary

This is an adaptive, randomised, double-blind, single-centre, placebo-controlled phase I, First in Human study designed to evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous dosing of ANXV in healthy male subjects.

Conditions

  • Healthy

Interventions

BIOLOGICAL

ANXV

Intravenous infusion

OTHER

Placebo

Intravenous infusion

Sponsors & Collaborators

  • Annexin Pharmaceuticals AB

    lead INDUSTRY

Principal Investigators

  • Anna Frostegård, MD, PhD · Annexin Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2021-10-27
Completion
2021-10-27

Countries

  • Netherlands

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 NCT04850339 on ClinicalTrials.gov