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OpenTrials
Completed

NCT Number: NCT05844592

First in Human, Single Ascending Dose Study

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Innovo Therapeutics, Inc.

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INV-101

Drug

subjects will be randomized 3:1 ratio

Primary outcomes

  1. AE

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

Innovo Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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