First in Human, Single Ascending Dose Study

Innovo Therapeutics

Status and phase: Completed; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: INV-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05844592

INV101-01

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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40 participants in 5 patient groups, including a placebo group

A

Placebo Comparator group

Description:

Dose A

Treatment:

Drug: INV-101

B

Placebo Comparator group

Description:

Dose B

Treatment:

Drug: INV-101

C

Placebo Comparator group

Description:

Dose C

Treatment:

Drug: INV-101

D

Placebo Comparator group

Description:

Dose D

Treatment:

Drug: INV-101

E

Placebo Comparator group

Description:

Dose E

Treatment:

Drug: INV-101