First in Human, Single Ascending Dose Study

Innovo Therapeutics, Inc.40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ulcerative Colitis

Interventions

INV-101DRUG

subjects will be randomized 3:1 ratio

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Innovo Therapeutics, Inc.

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 2 weeks

Data from ClinicalTrials.gov

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