First in Human, Single Ascending Dose Study

April 25, 2023 updated by: Innovo Therapeutics, Inc.

A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of INV-101 Administered Orally to Healthy Adult Subjects

The goal of this study is to evaluate the safety and tolerability of single ascending oral doses of INV-101 in healthy adult subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy, adult, male or female (of non-childbearing potential only), 19-55 years of age, inclusive, at the screening visit.
  • Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.

Exclusion Criteria:

  • Mentally or legally incapacitated or had significant emotional problems at the time of the screening visit or expected during the conduct of the study.
  • History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A
Dose A
Drug: INV-101
subjects will be randomized 3:1 ratio
Placebo Comparator: B
Dose B
Drug: INV-101
subjects will be randomized 3:1 ratio
Placebo Comparator: C
Dose C
Drug: INV-101
subjects will be randomized 3:1 ratio
Placebo Comparator: D
Dose D
Drug: INV-101
subjects will be randomized 3:1 ratio
Placebo Comparator: E
Dose E
Drug: INV-101
subjects will be randomized 3:1 ratio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE
Time Frame: 2 weeks
Number and severity of treatment-emergent adverse events (TEAEs) following single oral doses of INV-101 and placebo.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovo Therapeutics, Inc.

Investigators

  • Study Director: Minjeong Kim, Master, New Drug development Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2022

Primary Completion (Actual)

July 16, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Estimate)

May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INV101-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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