Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
WP1122 · 1 trial · 1 indication
To investigate the safety and tolerability of escalating doses of WP1122 administered as a single PO dose in sequential cohorts of healthy volunteers and to determine the MTD
To investigate the safety and tolerability of 7 days of escalating doses of WP1122 administered q12h PO in sequential cohorts of healthy volunteers and to determine the recommended dose for a Phase 2 trial in patients with COVID-19 (RP2D).
| Arm | Type | Description |
|---|---|---|
| WP1122 | EXPERIMENTAL | Each study group consists of 10 volunteers randomized in a 4:1 ratio to receive WP1122 or placebo. In the first part of the study (Single Ascending Dose \[SAD\]) in each group (up to 4), 8 volunteers will receive WP1122 and 2 volunteers will receive placebo, one time orally. A total of up to 40 volunteers will be enrolled into the SAD portion of the study. The second part of the study (Multiple Ascending Dose \[MAD\]) will begin when the third group in the SAD part of the study has completed dosing. In this part of the study (MAD) in each group (up to 4), 8 volunteers will receive WP1122 and 2 volunteers will receive placebo, 2 times per day (12 hours apart) orally for 7 days. A total of up to 40 volunteers will be enrolled into the MAD portion of the study. Up to 80 volunteers will be enrolled into the study entirely. |
| Placebo | PLACEBO_COMPARATOR | Each study group consists of 10 volunteers randomized in a 4:1 ratio to receive WP1122 or placebo. In the first part of the study (Single Ascending Dose \[SAD\]) in each group (up to 4), 8 volunteers will receive WP1122 and 2 volunteers will receive placebo, one time orally. A total of up to 40 volunteers will be enrolled into the SAD portion of the study. The second part of the study (Multiple Ascending Dose \[MAD\]) will begin when the third group in the SAD part of the study has completed dosing. In this part of the study (MAD) in each group (up to 4), 8 volunteers will receive WP1122 and 2 volunteers will receive placebo, 2 times per day (12 hours apart) orally for 7 days. A total of up to 40 volunteers will be enrolled into the MAD portion of the study. Up to 80 volunteers will be enrolled into the study entirely. |
| Name | Type | Description |
|---|---|---|
| WP1122 | DRUG | Oral solution |
| Placebo | DRUG | Oral solution |
Inclusion Criteria: 1. Subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form; 2. Subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is li...
WP1122 is an investigational small molecule developed by Moleculin Biotech, Inc. It has been studied in a Phase 1 clinical trial in healthy volunteers. The specific disease indications for WP1122 have not been publicly disclosed, and the compound remains in clinical development.
WP1122 is being developed by Moleculin Biotech, Inc., a biopharmaceutical company whose common stock trades on the Nasdaq Capital Market under the ticker symbol MBRX. Moleculin is the sponsor of the clinical program for WP1122.
WP1122 is in Phase 1 clinical development. The completed Phase 1 trial evaluated the safety and pharmacokinetics of WP1122 in healthy volunteers. No later-phase trials have been reported, and the drug is not approved for any indication.
WP1122 has been evaluated in one completed clinical trial, NCT05195723, titled "Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers." The Phase 1 trial enrolled 48 participants in the United Kingdom and was randomized, double-blind, and placebo-controlled.
No. WP1122 is an investigational drug and has not been approved by the FDA or any other regulatory agency. It has completed a Phase 1 trial in healthy volunteers, and further clinical development would be required before any potential approval.