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This study in healthy human volunteers will investigate the effects of a single dose (SAD) and multiple days of dosing (MAD) of WP1122 administered as an oral (PO) solution. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has completed at least 3 dosing cohorts in which WP1122 is found to be safe and well-tolerated. This study in healthy volunteers will explore safety and PK, and subsequent clinical development will be in patients infected with SARS CoV-2 in the setting of continued safety and favorable risk/benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WP1122 | Drug | Oral solution |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety in Single Ascending Dose (SAD) | 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 | 5 weeks |
| Safety in Multiple Ascending Dose (MAD) | 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). | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) in Single Ascending Dose | To examine the activity of WP1122 in the body following a single PO dose of WP1122. | 5 weeks |
| Maximum Plasma Concentration (Cmax) in Multiple Ascending Dose |
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Inclusion Criteria:
Subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form;
Subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned;
Male or female, aged 18 to 55 years (inclusive) at the time of signing the informed consent form (ICF);
Subject must be willing to undergo COVID-19 testing per clinical pharmacology unit /Phase 1 clinic guidelines;
Subject must complete full COVID-19 vaccination course at least 2 weeks prior to study drug administration;
Minimum body weight of ≥50 kg (110 lbs) for men and ≥45 kg (99 lbs) for women. Maximum body weight of ≤100 kg (220 lbs). Body Mass Index from 18 to 30 kg/m2 (values rounded to the nearest 10th of a unit);
Healthy as determined by a responsible and experienced physician, based on a medical evaluation, including medical history, physical examination, laboratory tests, and ECG:
Women of childbearing potential (WOCBP*) must use a highly effective form of birth control (confirmed by the Investigator). Rhythm methods will not be considered as a highly effective method of birth control. Highly effective forms of birth control include:
Non-vasectomized male volunteers must use an adequate method of contraception (condom with spermicide) from signing the ICF throughout the study duration and until 30 days after the last dose of study drug. Male volunteers must not donate sperm from time of signing the ICF until at least 30 days after the last dose of the study drug.
Exclusion Criteria:
Women who are pregnant, breastfeeding or intending to become pregnant, or men intending to father children within the projected duration of the trial from screening until 14 days following last dose;
Currently participating in or has participated in a study with an investigational product (IP) within 30 days or 5 half-lives, whichever is longer, preceding Day -1;
Due to the current pandemic:
Current or history of the following medical conditions:
i) QTcF ≥430 msec; History or family history of clinically significant or unstable ECG abnormalities (e.g., prolonged QT syndrome [torsade de pointes] or arrhythmias, including QT prolongation due to medical treatment), sudden cardiac death at a young age, or current use of a QT prolonging drug ii) Angina; iii) Congestive heart failure; iv) Myocardial infarction within the previous 6 months; v) Diastolic dysfunction; vi) Coronary artery disease; h. Malignancy within 5 years of screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence);
Immunosuppression as a result of underlying illness or treatment including:
History of substance or alcohol abuse and positive urine drug testing at screening. Subjects with a history of substance or alcohol abuse and negative urine drug testing at screening can be enrolled in study based on the Investigator's discretion;
Any physical examination findings and/or history of any illness that, in the opinion of the study Investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study;
Functional disorders of the gastrointestinal (GI) tract and/or surgical procedures that have been conducted (e.g. bariatric surgery, cholecystectomy) which could preclude the ability to adequately allow for effective absorption, distribution, metabolism, or excretion of the drug;
Diagnostic Assessments:
A positive test pre-study for hepatitis C antibody, Hepatitis B surface antigen (HbsAg), or human immunodeficiency virus (HIV) antibody;
Hemoglobin A1c ≥ULN;
Serum creatinine greater than or equal to ULN;
Estimated glomerular filtration rate <90 mL/minute as calculated by the chronic kidney disease CKD-EPI formula:
GFR = 141 * min(Scr/κ,1)α * max(Scr/κ,1) -1.209 * 0.993Age * 1.018 [if female] * 1.159 [if black]
Albumin to creatinine ratio (ACR) ≥0.03 mg/mg. In the event of an ACR above this threshold, eligibility must be confirmed by a second measurement;
Qualitative urinalysis test for blood, or glucose in urine. In the event of a positive test, the test will be repeated once, and if negative, the subject will be considered eligible;
A positive pre-study drug screen or unwilling to refrain from use of the illicit drugs and adhere to other protocol-stated restrictions while participating in the study, including follow-up.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicines Evaluation Unit | Manchester | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 30, 2023 | |
| Reset | May 10, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 30, 2023 | May 10, 2024 |
| ID | Term |
|---|---|
| C000722719 | 3,6-di-O-acetyl-2-deoxy-D-glucopyranose |
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| Drug |
Oral solution |
|
To examine the activity of WP1122 in the body following 7 days of q12h PO dosing.
| 10 weeks |