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

Trial ID or NCT#

NCT06346509

Status

recruiting iconRECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: 18 to 55
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. * 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.
    1. Exclusion Criteria:-
  2. * 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.
Exclusion Criteria:
  1. -
    1. * 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.
View All Criteria
Show Less

Investigator(s)

Peter Schmidt
Peter Schmidt
Anesthesiologist, Pain management specialist
Clinical Assistant Professor, Anesthesiology, Perioperative and Pain Medicine

Contact us to find out if this trial is right for you.

Contact

Portal Therapeutics, Chief Medical Officer
650-391-9740

SEND MESSAGE

View on ClinicalTrials.gov