Healthy Adult ParticipantsPhase 1NCT06346509
Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of PORT-77 Administered to Healthy Adult Participants
A Phase 1 study testing PORT-77 in people with Healthy Adult Participants, run by Portal Therapeutics, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- PORT-77
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to 20 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Adult Participants
- Being tested
- PORT-77, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PORT-77Drug
Healthy adult participants will receive PORT 77.
PlaceboDrug
Healthy adult participants will receive matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| PORT-77 | Experimental | Healthy adult participants will receive PORT 77. Receives: Drug: PORT-77 |
| Placebo | Placebo comparator | Healthy adult participants will receive matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I)
Measured: Day 8
Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II and III)
Measured: Day 21
Secondary outcomes (5)
Plasma concentration of a single-dose of PORT-77 (Part I)
Measured: Day 8
Plasma concentration of the steady-state of PORT-77 (Part II and III)
Measured: Day 21
Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I)
Measured: Day 4
Evaluate effects of single doses of PORT-77 on ECG parameters (Part I)
Measured: Day 8
Evaluate effects of multiple doses of PORT-77 on ECG parameters (Part II and III)
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start8 Apr 2024
- Primary completion27 Dec 2025
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portal Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Portal Therapeutics, Chief Medical Officer, Study director, Portal Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346509
- Sponsor's protocol ID
- PORT-77-101
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06346509
- Acronym / sponsor ID
- PORT-77-101
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Portal Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 27 Dec 2025 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PORT-77 | Experimental | Drug: PORT-77Healthy adult participants will receive PORT 77. |
| Placebo | Placebo comparator | Drug: PlaceboHealthy adult participants will receive matching placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PORT-77Healthy adult participants will receive PORT 77. | Drug | PORT-77 |
| PlaceboHealthy adult participants will receive matching placebo. | Drug | Placebo |
Primary outcome
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I)
Time frame: Day 8
Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II and III)
Time frame: Day 21
5 secondary outcomes
Plasma concentration of a single-dose of PORT-77 (Part I)
Time frame: Day 8
Plasma concentration of the steady-state of PORT-77 (Part II and III)
Time frame: Day 21
Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I)
Time frame: Day 4
Evaluate effects of single doses of PORT-77 on ECG parameters (Part I)
Time frame: Day 8
Evaluate effects of multiple doses of PORT-77 on ECG parameters (Part II and III)
Time frame: Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Portal Therapeutics, Chief Medical Officer study director
Portal Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PORT-77 in people with Healthy Adult Participants, run by Portal Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I) (time frame: Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.