PORT-77 for Healthy Adults

Overseen By Portal Therapeutics, Chief Medical Officer

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Portal Therapeutics, Inc.

Disqualifiers: Pregnancy, Lactation, Psychiatric condition, others

Compensation: Varies

Number of Visits: 1

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy adults with no significant medical history, it's likely that participants should not be on any regular medications.

What safety data exists for PORT-77 in clinical trials?

The research articles provided do not contain specific safety data for PORT-77 or any treatment evaluated under different names that could be directly linked to PORT-77. ^{1 2 3 4 5}

Who Is on the Research Team?

Portal Therapeutics, Chief Medical Officer

Principal Investigator

Portal Therapeutics

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to test the safety and effects of a new medication, PORT-77. Specific eligibility criteria are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

Participants must be 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

All healthy adult participants must be willing and able to follow protocol-specified assessments

Exclusion Criteria

I am mentally capable and emotionally stable to participate in the study.

I am not pregnant or breastfeeding.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose

Participants receive a single oral dose of PORT-77 or placebo

1 day

1 visit (in-person)

Multiple Ascending Dose

Participants receive multiple doses of PORT-77 or placebo to assess safety and tolerability

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PORT-77

Trial Overview The trial is testing PORT-77 against a placebo (a substance with no therapeutic effect). It's designed to see how people react to different doses of PORT-77 and what happens when they take it with food.

How Is the Trial Designed?

Group I: PORT-77 Experimental Treatment 1 Intervention

Healthy adult participants in each cohort will receive a single oral dose of PORT 77 or matching placebo on Day 1.

Group II: Placebo Placebo Group 1 Intervention

Healthy adult participants in each cohort will receive a single oral dose of PORT 77 or matching placebo on Day 1.

Who Is Running the Clinical Trial?

Portal Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

110+

Published Research Related to This Trial

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

In a five-year analysis of 1,559 healthy volunteers across 142 phase I studies, the overall incidence of adverse events (AEs) was 8.8%, with most AEs being mild or moderate in severity, indicating that while AEs are common, they are generally not severe.

The incidence of AEs was significantly higher in multiple-dose studies compared to single-dose trials, highlighting the importance of study design in assessing the safety profile of active drugs, with a notable increase in AEs on the first day of drug administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. Lutfullin, A., Kuhlmann, J., Wensing, G.[2019]

The study demonstrated that it is feasible and acceptable to collect self-reported symptoms, function, and quality of life (QOL) data from pediatric cancer patients aged 8 to 18 enrolled in phase 1/2 clinical trials, with a high enrollment rate of 75.9%.

The findings indicated that while most measures were reliable, the validity of the results was limited; specifically, as adverse events increased, patients reported decreased mobility and increased fatigue, suggesting that patient-reported outcomes could serve as valuable endpoints in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voices of children and adolescents on phase 1 or phase 2 cancer trials: A new trial endpoint? Hinds, PS., Wang, J., Stern, ED., et al.[2020]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

In Australia, the increasing requirements for reporting adverse events (AEs) and serious AEs (SAEs) in medical research are leading to unnecessary burdens on researchers, particularly affecting less funded investigator-initiated trials.

The authors argue that individual AE reports are often not useful in blinded studies, and suggest that a trial data safety and monitoring committee should handle safety data analysis, which would streamline reporting and focus on meaningful safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse event reporting in investigator-initiated clinical trials. Wallace, S., Myles, PS., Zeps, N., et al.[2022]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Voices of children and adolescents on phase 1 or phase 2 cancer trials: A new trial endpoint? [2020]

4. United States pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. [2009]

5. Australia pubmed.ncbi.nlm.nih.gov

Serious adverse event reporting in investigator-initiated clinical trials. [2022]