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Safety, Tolerability and Pharmacokinetics Trial of JDP-205 Injection 10 mg

NCT02024152 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-03-06

No results posted yet for this study

Summary

This study is to investigate the pharmacokinetics (PK) together with the safety and tolerability of JDP-205 at 5 mg and 10 mg intravenous doses and 10 mg intramuscular dose, in comparison to the marketed cetirizine oral product Zyrtec® 10 mg tablets (an OTC product) in healthy male and female volunteers after a single dose administration.

Conditions

  • Acute Urticaria

Interventions

DRUG

JDP-205 IV high dose

DRUG

JDP-205 IV low dose

DRUG

JDP-205 IM

DRUG

Control: Zyrtec

Sponsors & Collaborators

  • Algorithme Pharma Inc

    collaborator INDUSTRY

  • JDP Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Canada

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 NCT02024152 on ClinicalTrials.gov