Single Ascending Dose, Multiple Ascending Dose, Food Effect Study

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: INV-101; Drug: INV-101 Placebo

• Registration Number: NCT06938204
• Lead Sponsor: Innovo Therapeutics, Inc.

Brief Summary

This is a 2-part study. Parts 1 and 2 will be a randomized, double-blind, placebo-controlled investigations of SAD (Part 1) and MAD (Part 2) of orally administered INV-101 in healthy adult subjects. Food effect will also be assessed in one cohort in Part 1.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Primary Completion: 2024-08-09
• Study Completion: 2024-09-13
• Status Verified: 2025-04
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Male subjects must follow protocol specified contraception guidance as described in Section 7.4.5 and agree to refrain from sperm donation until 90 days after the last dosing.
• Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee at the screening visit, including the following:

Exclusion Criteria

1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
4. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
5. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the study drug or study drug excipients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SAD A	INV-101	-
SAD A	INV-101 Placebo	-
SAD B	INV-101	-
SAD B	INV-101 Placebo	-
SAD C	INV-101	-
SAD C	INV-101 Placebo	-
MAD A	INV-101	-
MAD A	INV-101 Placebo	-
MAD B	INV-101 Placebo	-
MAD C	INV-101	-
MAD B	INV-101	-
MAD C	INV-101 Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety Analysis	7 days after last dosing	Adverse Events: AEs will be coded using the most current version of Medical Dictionary for Regulatory Activities® (MedDRA®). A by-subject AE data listing, including verbatim term, preferred term, treatment (INV-101 or placebo), severity, and relationship to drug, will be provided. The number of subjects experiencing treatment-emergent adverse events (TEAEs) and the number of TEAEs will be summarized by study part and treatment (INV-101 or placebo) using frequency counts.

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)	3 days	AUC0-12, AUC0-t, AUC0-inf
Peak Plasma Concentration (Cmax)	3 days

Trial Locations

Locations (1)

Pharmaron; 🇺🇸 Baltimore, Maryland, United States