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

NCT06346509 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PORT-77-101
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I)

  Day 8

• Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II and III)

  Day 21

Secondary Outcomes (5)

• Plasma concentration of a single-dose of PORT-77 (Part I)

  Day 8

• Plasma concentration of the steady-state of PORT-77 (Part II and III)

  Day 21

• Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I)

  Day 4

• Evaluate effects of single doses of PORT-77 on ECG parameters (Part I)

  Day 8

• Evaluate effects of multiple doses of PORT-77 on ECG parameters (Part II and III)

  Day 21

Study Arms (2)

PORT-77

EXPERIMENTAL

Healthy adult participants will receive PORT 77.

Drug: PORT-77

Placebo

PLACEBO COMPARATOR

Healthy adult participants will receive matching placebo.

Drug: Placebo

Interventions

PORT-77 DRUG

Healthy adult participants will receive PORT 77.

PORT-77

Placebo DRUG

Healthy adult participants will receive matching placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Portal Therapeutics, Inc.: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Study Officials

• Portal Therapeutics, Chief Medical Officer

  Portal Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 4, 2024
• Study Start: April 8, 2024
• Primary Completion: December 27, 2025
• Study Completion: January 20, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)