Healthy Volunteer
Conditions
Keywords
PN-881
Brief summary
The goal of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PN-881 in healthy adult participants.
Detailed description
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.
Interventions
DRUGPN-881 Oral Solution
PN-881 Oral Solution
DRUGPN-881 Oral Tablet
PN-881 oral tablet
DRUGPlacebo
Placebo
Sponsors
Protagonist Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Part 1 & Part 2 is masked; Part 3, Part 4 and Part 5 are open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female participants of non-childbearing potential, aged 18-65 years inclusive 2. Body mass index (BMI) between 18 and 32 kg/m² (inclusive) at screening 3. Willing and able to comply with all study requirements and provide written informed consent 4. 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
1. Clinically significant history or presence of cardiovascular, gastrointestinal, hepatic, renal, neurological, psychiatric, or allergic diseases 2. History of neoplastic disease (except adequately treated non-melanoma skin cancer) 3. Positive test for hepatitis B, hepatitis C, or HIV at screening 4. History of substance abuse or recreational IV drug use within the past 2 years 5. Clinically significant infection or fever (\>38°C) within 2 weeks prior to screening 6. Use of any prescription/non-prescription drugs or herbal supplements within 7 days or 5 half-lives before dosing (unless approved by investigator) 7. Supine blood pressure or ECG abnormalities outside protocol-defined ranges 8. Use of tobacco/nicotine products exceeding 5 cigarettes/day or 2 chews/day 9. Consumption of \>21 alcohol units/week (males) or \>14 units/week (females)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Predose to 7 days after last dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of PN-881 | 48 hours following the first dose and the last dose | Highest measured plasma concentration of PN-881 following oral administration. |
| Area under the plasma concentration-time curve (AUC) of PN-881 | Predose to 48 hours after the first and last dose. | AUC calculated from 0 to infinity. |
| Levels of biomarker in serum | Day 1 Predose up to 48 hours post (last) dose | Pharmacodynamics (PD) of PN-881 by means of increase in levels of biomarker by PN-881 after single and multiple oral doses. |
Countries
Australia
Outcome results
None listed