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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 being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing its safety and pharmacokinetics. The drug is being developed by Moleculin Biotech, Inc. and is not yet approved for any medical use.
WP1122 is being developed by Moleculin Biotech, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MBRX. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational small molecule drug.
WP1122 is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the safety and pharmacokinetics of the drug in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities for any indication.
WP1122 has one completed clinical trial, NCT05195723, titled "Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers." This Phase 1 study enrolled 48 participants in the United Kingdom and was a randomized, double-blind, placebo-controlled trial.
WP1122 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed Phase 1 trial has assessed its safety and pharmacokinetics in healthy volunteers, but the drug has not yet received regulatory approval for any medical use.
WP1122 is a distinct investigational small molecule developed by Moleculin Biotech, Inc. No alternative names for this drug have been reported in clinical trial registrations. It is being studied under its unique identifier in a Phase 1 healthy volunteer trial.