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Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects

NCT05068947 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-10-17

No results posted yet for this study

Summary

This is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study.

Conditions

  • Phase 1

Interventions

DRUG

GV101

GV101 administered once orally.

DRUG

Placebo

Matched placebo

Sponsors & Collaborators

  • Graviton Bioscience Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-09-10
Primary Completion
2021-10-22
Completion
2021-10-22
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 NCT05068947 on ClinicalTrials.gov