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

Healthy Adult Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346509
• Other study ID #: PORT-77-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 8, 2024
• Est. completion date: December 23, 2024

Study information

• Verified date: March 2024
• Source: Portal Therapeutics, Inc.
• Contact: Portal Therapeutics, SVP Clinical Development
• Phone: 650-391-9740
• Email: Portal.clinical.trials[@]bridgebio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: December 23, 2024
• Est. primary completion date: December 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adult Participants

Intervention

Drug:
• PORT-77
Healthy adult participants will receive a single oral dose of PORT 77.
• Placebo
Healthy adult participants will receive matching placebo on Day 1.

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Portal Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I)		Day 8
Primary	Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II)		Day 21
Secondary	Plasma concentration of a single-dose of PORT-77 (Part I)		Day 8
Secondary	Plasma concentration of the steady-state of PORT-77 (Part II)		Day 21
Secondary	Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I)		Day 4
Secondary	Evaluate effects of single doses of PORT-77 on ECG parameters (Part I)		Day 8
Secondary	Evaluate effects of single doses of PORT-77 on ECG parameters (Part II)		Day 21