First in Human, Single Ascending Dose Study

Phase 1

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: INV-101

• Registration Number: NCT05844592
• Lead Sponsor: Innovo Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-21
• Primary Completion: 2022-07-16
• Study Completion: 2022-08-31
• Status Verified: 2023-04
• Study First Submitted: 2023-04-25
• Study First Submitted QC: 2023-04-25
• Last Update Submitted: 2023-04-25
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
D	INV-101	Dose D
C	INV-101	Dose C
E	INV-101	Dose E
B	INV-101	Dose B
A	INV-101	Dose A

Primary Outcome Measures

Name	Time	Method
AE	2 weeks	Number and severity of treatment-emergent adverse events (TEAEs) following single oral doses of INV-101 and placebo.

Trial Locations

Locations (1)

Innovo Therapeutics, Inc.; 🇰🇷 Seoul, Korea, Republic of