Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of PORT-77 Administered to Healthy Adult Participants
- Registration Number
- NCT06346509
- Lead Sponsor
- Portal Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 108
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo Healthy adult participants in each cohort will receive a single oral dose of PORT 77 or matching placebo on Day 1. PORT-77 PORT-77 Healthy adult participants in each cohort will receive a single oral dose of PORT 77 or matching placebo on Day 1.
- Primary Outcome Measures
Name Time Method Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II) Day 21 Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I) Day 8
- Secondary Outcome Measures
Name Time Method Plasma concentration of a single-dose of PORT-77 (Part I) Day 8 Evaluate effects of single doses of PORT-77 on ECG parameters (Part I) Day 8 Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I) Day 4 Plasma concentration of the steady-state of PORT-77 (Part II) Day 21 Evaluate effects of single doses of PORT-77 on ECG parameters (Part II) Day 21
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States