Single Ascending Dose, Multiple Ascending Dose, Food Effect Study

Innovo Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06938204

INV101-02

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 6 patient groups

SAD A

Experimental group

Treatment:

Drug: INV-101

Drug: INV-101 Placebo

SAD B

Experimental group

Treatment:

Drug: INV-101

Drug: INV-101 Placebo

SAD C

Experimental group

Treatment:

Drug: INV-101

Drug: INV-101 Placebo

MAD A

Experimental group

Treatment:

Drug: INV-101

Drug: INV-101 Placebo

MAD B

Experimental group

Treatment:

Drug: INV-101

Drug: INV-101 Placebo

MAD C

Experimental group

Treatment:

Drug: INV-101

Drug: INV-101 Placebo