Testing PORT-77 in healthy adults
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
This study is testing a new drug called PORT-77 in healthy adults to see if it's safe and how it affects the body compared to a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Portal Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Tempe, Arizona) |
| Trial ID | NCT06346509 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and tolerability of PORT-77 through a randomized, double-blind, placebo-controlled design involving both single and multiple ascending doses. Healthy adult participants will receive either the drug or a placebo to assess its effects. The study aims to gather data on how the drug is processed in the body and its potential side effects. Participants will undergo various assessments to ensure they meet health criteria and can follow the study protocol.
Who should consider this trial
Good fit: Ideal candidates are healthy adult individuals without significant medical or psychiatric conditions.
Not a fit: Patients with significant medical or psychiatric conditions or those who are pregnant or lactating will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of a new therapeutic option for future medical applications.
How similar studies have performed: While this approach is common in early-phase drug testing, the specific drug PORT-77 has not been previously tested in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tempe, Arizona
- Celerion — Tempe, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Portal Therapeutics, Chief Medical Officer
- Email: Portal.clinical.trials@gondolabio.com
- Phone: 650-391-9740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.