CClinicalTrials.gg
Sign In
CompletedNCT06346509Updated Apr 20, 2026

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

A Phase 1 interventional study of PORT-77 and Placebo in Healthy Adult Participants, sponsored by Portal Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Portal Therapeutics, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Adult Participants
03

In context

Lead sponsor

Portal Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
156 participants (actual)

Study arms

  • Experimental
    PORT-77

    Healthy adult participants will receive PORT 77.

    Drug: PORT-77

  • Placebo comparator
    Placebo

    Healthy adult participants will receive matching placebo.

    Drug: Placebo

Interventions

  • DrugPORT-77

    Healthy adult participants will receive PORT 77.

  • DrugPlacebo

    Healthy adult participants will receive matching placebo.

06

What researchers measure

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

07

Study locations

1 site
  • Celerion
    Tempe, Arizona 85283, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06346509
Lead sponsor
Portal Therapeutics, Inc.
Responsible party
Sponsor
First posted
Apr 4, 2024
Start date
Apr 8, 2024
Primary completion
Dec 27, 2025
Completion
Jan 20, 2026
Last update
Apr 20, 2026

Study contacts

Portal Therapeutics, Chief Medical Officer
study director · Portal Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Portal Therapeutics, Inc.

Start the discussion