RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-08

Study Completion:2025-08-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06346509

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.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Portal Therapeutics, SVP Clinical Development

CONTACT

650-391-9740

Portal.clinical.trials@bridgebio.com

Principal Investigator

Portal Therapeutics, VP Clinical Development

STUDY_DIRECTOR

Portal Therapeutics

Study Locations (Sites)

Celerion

Tempe, Arizona, 85283

United States

Collaborators and Investigators

Sponsor: Portal Therapeutics, Inc.

Portal Therapeutics, VP Clinical Development, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-04-08

Study Completion Date2025-08-29

Study Record Updates

Study Start Date2024-04-08

Study Completion Date2025-08-29

Terms related to this study

Additional Relevant MeSH Terms

Healthy Adult Participants