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Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects

NCT04171115 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-04

Study results available
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Summary

A Phase 1, randomized, double-blind, placebo-controlled dose escalation trial of four dose cohorts of 10 subjects (1: 10mg, 2: 25mg, 3: 50mg, 4: 100mg).

Conditions

  • Healthy

Interventions

DRUG

G03-52-01

G03-52-01 administered intramuscularly

DRUG

Placebo

Placebo administered intramuscularly

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Alachua Government Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Cassandra Key, MD · ICON Early Phase Services, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-08-20
Completion
2023-04-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04171115 on ClinicalTrials.gov