First in Human, Single Ascending Dose Study

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

INV-101

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Innovo Therapeutics, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Arm Label

A

B

C

D

E

Arm Description

Dose A

Dose B

Dose C

Dose D

Dose E

Outcomes

Primary Outcome Measures

AE

Number and severity of treatment-emergent adverse events (TEAEs) following single oral doses of INV-101 and placebo.

Secondary Outcome Measures

Full Information

NCT ID

NCT05844592

First Posted

April 25, 2023

Last Updated

April 25, 2023

Sponsor

Innovo Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05844592

Brief Title

First in Human, Single Ascending Dose Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

April 21, 2022 (Actual)

Primary Completion Date

July 16, 2022 (Actual)

Study Completion Date

August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovo Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Placebo Comparator

Arm Description

Dose A

Arm Title

B

Arm Type

Placebo Comparator

Arm Description

Dose B

Arm Title

C

Arm Type

Placebo Comparator

Arm Description

Dose C

Arm Title

D

Arm Type

Placebo Comparator

Arm Description

Dose D

Arm Title

E

Arm Type

Placebo Comparator

Arm Description

Dose E

Intervention Type

Drug

Intervention Name(s)

INV-101

Intervention Description

subjects will be randomized 3:1 ratio

Primary Outcome Measure Information:

Title

AE

Description

Number and severity of treatment-emergent adverse events (TEAEs) following single oral doses of INV-101 and placebo.

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minjeong Kim, Master

Organizational Affiliation

New Drug development Center

Official's Role

Study Director

Facility Information:

Facility Name

Innovo Therapeutics, Inc.

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

No

Ulcerative Colitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial