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PN-881 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| PN-881 Oral Solution Single Ascending Dose | EXPERIMENTAL | PN-881 Oral Solution Single Ascending Dose |
| Placebo Oral Solution Single Ascending Dose | PLACEBO_COMPARATOR | Placebo single ascending doses |
| PN-881 Oral Solution Multiple Ascending Dose | EXPERIMENTAL | PN-881 Multiple Ascending Doses |
| Placebo Oral Solution Multiple Ascending Dose | PLACEBO_COMPARATOR | Placebo, multiple ascending doses |
| PN-881 Oral Tablet Single Dose | EXPERIMENTAL | PN-881 oral tablet single dose |
| PN-881 Oral Tablet Multiple Dose | EXPERIMENTAL | PN-881 oral tablet multiple dose |
| Name | Type | Description |
|---|---|---|
| PN-881 Oral Solution | DRUG | PN-881 Oral Solution |
| PN-881 Oral Tablet | DRUG | PN-881 oral tablet |
| Placebo | DRUG | Placebo |
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 part...
PN-881 is an investigational small molecule being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects. It is not approved for any indication.
PN-881 is being developed by Protagonist Therapeutics, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol PTGX. The drug is currently in Phase 1 clinical development, with one completed trial in healthy volunteers.
PN-881 is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied the drug in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities. It is not yet in later-stage clinical trials.
PN-881 has one completed Phase 1 clinical trial, identified as NCT07153146. This trial was titled "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects." It enrolled 146 participants in Australia and was a randomized, double-blind, placebo-controlled study.
PN-881 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 trial in healthy volunteers has been completed, but the drug has not yet received regulatory approval for any use. Further clinical studies would be needed for approval.