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NCT05844592 Clinical Trial

First in Human, Single Ascending Dose Study

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05844592
Other study ID # INV101-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 21, 2022
Est. completion date August 31, 2022

Study information
Verified date April 2023
Source Innovo Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 31, 2022
Est. primary completion date July 16, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• INV-101
subjects will be randomized 3:1 ratio

Locations
Country Name City State
Korea, Republic of Innovo Therapeutics, Inc. Seoul

Sponsors (1)
Lead Sponsor Collaborator
Innovo Therapeutics, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AE Number and severity of treatment-emergent adverse events (TEAEs) following single oral doses of INV-101 and placebo. 2 weeks
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