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NAVX-010-Phase I Tolerability and Pharmacokinetic Study in Healthy Male Subjects

NCT03655522 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-31

No results posted yet for this study

Summary

This was a double-blind, placebo-controlled, randomized, single ascending dose, sequential group study. Each subject participated in only 1 treatment period.

The primary objective was to determine the safety of single intramuscular (IM) injections of NAVX 010 in healthy subjects. The secondary objective was to determine the single dose pharmacokinetics (PK) of Gonyautoxin 2 (GTX 2) and Gonyautoxin 3 (GTX 3) following IM administration of NAVX 010 in healthy subjects.

Thirty subjects were studied in 5 groups (Groups A to E); each group consisted of 6 subjects, of which 4 subjects received the Investigational Medicinal Product and 2 subjects received placebo. All subjects completed the study and data for all subjects were included in the safety analyses. A total of 20 subjects received NAVX-010 and were included in the PK population and subsequent PK analysis.

Conditions

  • Safety

Interventions

DRUG

NAVX-010

Dose levels of NAVX-010 were 2, 8, 25, 50, and 75 mcg. Four patients per active group. Each subject participated in only 1 treatment period.

DRUG

Placebo

There were two Placebos per group.

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Algenis SpA

    lead INDUSTRY

Principal Investigators

  • Kelly M Whitehurst, MD · Covance Clinical Research Unit, Evansville

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2015-05-14
Primary Completion
2015-09-02
Completion
2015-09-02
FDA Drug
Yes

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Entities

Drugs

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 NCT03655522 on ClinicalTrials.gov