First in Human, Single Ascending Dose Study

NCT ID: NCT05844592

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2022-08-31

Brief Summary

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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

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Dose A

Group Type PLACEBO_COMPARATOR

INV-101

Intervention Type DRUG

subjects will be randomized 3:1 ratio

B

Dose B

Group Type PLACEBO_COMPARATOR

INV-101

Intervention Type DRUG

subjects will be randomized 3:1 ratio

C

Dose C

Group Type PLACEBO_COMPARATOR

INV-101

Intervention Type DRUG

subjects will be randomized 3:1 ratio

D

Dose D

Group Type PLACEBO_COMPARATOR

INV-101

Intervention Type DRUG

subjects will be randomized 3:1 ratio

E

Dose E

Group Type PLACEBO_COMPARATOR

INV-101

Intervention Type DRUG

subjects will be randomized 3:1 ratio

Interventions

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INV-101

subjects will be randomized 3:1 ratio

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Innovo Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minjeong Kim, Master

Role: STUDY_DIRECTOR

New Drug development Center

Locations

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Innovo Therapeutics, Inc.

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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INV101-01

Identifier Type: -

Identifier Source: org_study_id

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