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

Launched by PORTAL THERAPEUTICS, INC. · Mar 28, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called PORT-77 in healthy adults to see how safe and effective it is. The study is designed to find out how different doses of PORT-77 affect participants, and it will do this by comparing it to a placebo, which is an inactive substance that looks like the real drug. This trial is currently looking for volunteers aged 18 to 65 who are in good health and can follow the study rules. To be eligible, participants should not have any significant medical issues or be pregnant or breastfeeding.

If you decide to participate, you will undergo some health checks to ensure you meet the study requirements. During the trial, you will receive either PORT-77 or the placebo, but neither you nor the researchers will know which one you get. This helps keep the study fair and unbiased. The trial aims to gather important information that could help in future treatments, and your contribution could make a difference in medical research.

Gender

ALL

Eligibility 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.