Healthy Adult Participants
Conditions
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.
Interventions
DRUGPORT-77
Healthy adult participants will receive PORT 77.
DRUGPlacebo
Healthy adult participants will receive matching placebo.
Sponsors
Portal Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I) | Day 8 |
| Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II and III) | Day 21 |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration of a single-dose of PORT-77 (Part I) | Day 8 |
| Plasma concentration of the steady-state of PORT-77 (Part II and III) | Day 21 |
| Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I) | Day 4 |
| Evaluate effects of single doses of PORT-77 on ECG parameters (Part I) | Day 8 |
| Evaluate effects of multiple doses of PORT-77 on ECG parameters (Part II and III) | Day 21 |
Countries
United States
Contacts
STUDY_DIRECTORPortal Therapeutics, Chief Medical Officer
Portal Therapeutics
Outcome results
None listed