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OpenTrials
Completed

NCT Number: NCT06346509

Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of PORT-77 Administered 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.

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Key information

Conditions

Healthy Adult Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PORT-77

Drug

Healthy adult participants will receive PORT 77.

Placebo

Drug

Healthy adult participants will receive matching placebo.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

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

    Time frame: Day 8

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

    Time frame: Day 21

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

    Time frame: Day 4

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

    Time frame: Day 8

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

    Time frame: Day 21

Sponsors and collaborators

Lead sponsor

Portal Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 4, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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