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First in Human, Single Ascending Dose Study

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
INV-101
Sponsored by
Innovo Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Placebo Comparator

Placebo Comparator

Placebo Comparator

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

First Posted
April 25, 2023
Last Updated
April 25, 2023
Sponsor
Innovo Therapeutics, Inc.
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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
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

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First in Human, Single Ascending Dose Study

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