NCT05844592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

April 25, 2023

Last Update Submit

April 25, 2023

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • AE

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

    2 weeks

Study Arms (5)

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

INV-101DRUG

subjects will be randomized 3:1 ratio

ABCDE

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovo Therapeutics, Inc.

Seoul, South Korea

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Minjeong Kim, Master

    New Drug development Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 6, 2023

Study Start

April 21, 2022

Primary Completion

July 16, 2022

Study Completion

August 31, 2022

Last Updated

May 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)