Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of PORT-77 Administered to Healthy Adult Participants

Portal Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Healthy Adult Participants

Treatments: Drug: Placebo; Drug: PORT-77

Study type: Interventional

Funder types: Industry

Identifiers

NCT06346509

PORT-77-101

Details and patient eligibility

About

A First-in-Human 2-part, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose, and food effect, investigation of the administration of PORT-77 in healthy adult participants.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• All healthy adult participants must be willing and able to follow protocol-specified assessments.
• Healthy based on no clinically significant medical history, physical examination, laboratory profiles, vital signs, and Electrocardiograms (ECGs), as deemed by the Principal Investigator (PI) or designee.

Exclusion Criteria:-

• 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.
• Female subject with a positive pregnancy test at the screening visit or at first check-in or who is lactating.
• Participation in another clinical study within 60 days or within 10 half-lives (if known), prior to the first dosing, whichever is longer, or previous participation in another PORT 77 study or study part.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

108 participants in 2 patient groups, including a placebo group

PORT-77

Experimental group

Description:

Healthy adult participants in each cohort will receive a single oral dose of PORT 77 or matching placebo on Day 1.

Treatment:

Drug: PORT-77

Placebo

Placebo Comparator group

Description:

Healthy adult participants in each cohort will receive a single oral dose of PORT 77 or matching placebo on Day 1.

Treatment:

Drug: Placebo