Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05195723 | Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers | PHASE1 | COMPLETED | 48 | — | — | May 11, 2022 | Oct 24, 2022 | Feb 27, 2023 | 1 | United Kingdom |
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...