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

Description

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.

Conditions

Healthy Adult Participants

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Study Overview

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Study Details

Study overview

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.

A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose and Food Effect Study of PORT-77 Administered Orally to Healthy Adult Participants

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

Condition
Healthy Adult Participants
Intervention / Treatment

-

Contacts and Locations

Tempe

Celerion, Tempe, Arizona, United States, 85283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Portal Therapeutics, Inc.,

Portal Therapeutics, VP Clinical Development, STUDY_DIRECTOR, Portal Therapeutics

Study Record Dates

2025-08-29