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

April 15, 2026 updated by: Portal Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Celerion

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PORT-77
Healthy adult participants will receive PORT 77.
Drug: PORT-77
Healthy adult participants will receive PORT 77.
Placebo Comparator: Placebo
Healthy adult participants will receive matching placebo.
Drug: Placebo
Healthy adult participants will receive matching placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I)
Time Frame: Day 8
Day 8
Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II and III)
Time Frame: Day 21
Day 21

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of a single-dose of PORT-77 (Part I)
Time Frame: Day 8
Day 8
Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I)
Time Frame: Day 4
Day 4
Evaluate effects of single doses of PORT-77 on ECG parameters (Part I)
Time Frame: Day 8
Day 8
Plasma concentration of the steady-state of PORT-77 (Part II and III)
Time Frame: Day 21
Day 21
Evaluate effects of multiple doses of PORT-77 on ECG parameters (Part II and III)
Time Frame: Day 21
Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portal Therapeutics, Inc.

Investigators

  • Study Director: Portal Therapeutics, Chief Medical Officer, Portal Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2024

Primary Completion (Actual)

December 27, 2025

Study Completion (Actual)

January 20, 2026

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PORT-77-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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