Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.
The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants.
Study details:
PN-881 will be administered in oral solution and tablet formulations, with dosing under fasting or fed conditions depending on the study part. The study consists of five parts:. Part 1 - Single Ascending Dose (SAD): Randomised, double-blind, placebo-controlled Part 2 - Multiple Ascending Dose (MAD): Randomised, double-blind, placebo-controlled Part 3 - Tablet Formulation Comparison: Open-label, crossover design; participants will receive different oral tablet formulations Part 4 - Effect of Food: Open-label, crossover design to assess the effect of food on the pharmacokinetics of PN-881.
Participants will receive PN-881 tablet formulations in fasted and fed conditions. Part 5 - Dosing Frequency Comparison: Open-label, randomized study comparing once-daily and twice-daily dosing.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Healthy male and female participants of non-childbearing potential, aged 18-65 years inclusive
- Body mass index (BMI) between 18 and 32 kg/m² (inclusive) at screening
- Willing and able to comply with all study requirements and provide written informed consent
- Male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose
Exclusion criteria
- Clinically significant history or presence of cardiovascular, gastrointestinal, hepatic, renal, neurological, psychiatric, or allergic diseases
- History of neoplastic disease (except adequately treated non-melanoma skin cancer)
- Positive test for hepatitis B, hepatitis C, or HIV at screening
- History of substance abuse or recreational IV drug use within the past 2 years
- Clinically significant infection or fever (>38°C) within 2 weeks prior to screening
- Use of any prescription/non-prescription drugs or herbal supplements within 7 days or 5 half-lives before dosing (unless approved by investigator)
- Supine blood pressure or ECG abnormalities outside protocol-defined ranges
- Use of tobacco/nicotine products exceeding 5 cigarettes/day or 2 chews/day
- Consumption of >21 alcohol units/week (males) or >14 units/week (females)
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT07153146
Intervention or treatment
DRUG: PN-881 Oral Solution
DRUG: PN-881 Oral Tablet
DRUG: Placebo
Conditions
- Healthy Volunteer
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Research sites nearby
Closest Location:
Nucleus Network
Select from list below to view details:
Nucleus Network
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Protagonist Therapeutics, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: PN-881 Oral Solution Single Ascending Dose
| Drug: PN-881 Oral Solution |
PLACEBO_COMPARATOR: Placebo Oral Solution Single Ascending Dose
| Drug: Placebo |
EXPERIMENTAL: PN-881 Oral Solution Multiple Ascending Dose
| Drug: PN-881 Oral Solution |
PLACEBO_COMPARATOR: Placebo Oral Solution Multiple Ascending Dose
| Drug: Placebo |
EXPERIMENTAL: PN-881 Oral Tablet Single Dose
| Drug: PN-881 Oral Tablet |
EXPERIMENTAL: PN-881 Oral Tablet Multiple Dose
| Drug: PN-881 Oral Tablet |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Evaluate the safety and tolerability of PN-881 in comparison to placebo after single and multiple doses in healthy subjects assessed for severity, seriousness, and relation to the investigational product. | Predose to 7 days after last dose |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of PN-881 | Highest measured plasma concentration of PN-881 following oral administration. | 48 hours following the first dose and the last dose |
| Area under the plasma concentration-time curve (AUC) of PN-881 | AUC calculated from 0 to infinity. | Predose to 48 hrs after the first and last dose. |
| Levels of biomarker in serum | Pharmacodynamics (PD) of PN-881 by means of increase in levels of biomarker by PN-881 after single and multiple oral doses. | Day 1 Predose up to 48 hrs post (last) dose |
References
Clinical Trials Gov: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.Other trials to consider
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