Single Ascending Dose, Multiple Ascending Dose, Food Effect Study

NCT06938204 | Completed Phase 1 FDA Drug

• 1 other identifier: INV101-02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Safety Analysis

  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.

  7 days after last dosing

Secondary Outcomes (2)

• Area under the plasma concentration versus time curve (AUC)

  3 days

• Peak Plasma Concentration (Cmax)

  3 days

Study Arms (6)

SAD A

EXPERIMENTAL

Drug: INV-101; Drug: INV-101 Placebo

SAD B

EXPERIMENTAL

Drug: INV-101; Drug: INV-101 Placebo

SAD C

EXPERIMENTAL

Drug: INV-101; Drug: INV-101 Placebo

MAD A

EXPERIMENTAL

Drug: INV-101; Drug: INV-101 Placebo

MAD B

EXPERIMENTAL

Drug: INV-101; Drug: INV-101 Placebo

MAD C

EXPERIMENTAL

Drug: INV-101; Drug: INV-101 Placebo

Interventions

INV-101 DRUG

SAD MAD

MAD A; MAD B; MAD C; SAD A; SAD B; SAD C

INV-101 Placebo DRUG

SAD MAD

MAD A; MAD B; MAD C; SAD A; SAD B; SAD C

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

• 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.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
• 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.
• History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
• History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the study drug or study drug excipients.

Sponsors & Collaborators

• Innovo Therapeutics, Inc.: lead

Study Sites (1)

Pharmaron

Baltimore, Maryland, 02451, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 8 subjects were randomized to 6 Active and 2 Placebo in each cohort.

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 22, 2025
• Study Start: April 1, 2024
• Primary Completion: August 9, 2024
• Study Completion: September 13, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)