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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Adult Participants

In brief

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.

Key facts

Study ID

NCT06346509

Run by

Portal Therapeutics, Inc.

People needed

156

Starts

2024-04-08

Expected to finish

2026-01-20

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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