First in Human, Single Ascending Dose Study | NCT05844592

Studies
First in Human, Single Ascending Dose Study

NCT05844592

Sponsor

Innovo Therapeutics, Inc.

Status

Completed

Last Update Posted

May 6, 2023Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Ulcerative Colitis

Interventions

INV-101

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 21, 2022Actual

Primary Completion Date

Jul 16, 2022Actual

Completion Date

Aug 31, 2022Actual

First Submitted Date

Apr 25, 2023

First Submission Date that Met QC Criteria

Apr 25, 2023

First Posted Date

May 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2023

Last Update Posted Date

May 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Placebo Comparator	Dose A	Drug: INV-101
B	Placebo Comparator	Dose B	Drug: INV-101
C	Placebo Comparator	Dose C	Drug: INV-101
D	Placebo Comparator	Dose D	Drug: INV-101
E	Placebo Comparator	Dose E	Drug: INV-101

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INV-101	Drug	subjects will be randomized 3:1 ratio	A B C D E

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Minjeong Kim, Master	New Drug development Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Innovo Therapeutics, Inc.		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided