Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers

NCT05195723 | Completed Phase 1

• 1 other identifier: MB-301
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Maximum Plasma Concentration (Cmax) in Single Ascending Dose

  5 weeks

• Maximum Plasma Concentration (Cmax) in Multiple Ascending Dose

  10 weeks

Study Arms (2)

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.

Drug: WP1122

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.

Drug: Placebo

Interventions

WP1122 DRUG

Oral solution

WP1122

Placebo DRUG

Oral solution

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• No evidence of clinically significant cardiac, pulmonary, hepatic, biliary, gastrointestinal, or renal disorders, or cancer within the past 5 years (except localized or in situ cancer of the skin);
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, bilirubin, and creatinine lower than or equal to the ULN. Abnormal values can be repeated once at the discretion of the Investigator or designee;
• White blood cell count (including differential), hemoglobin and platelets must be above the lower limit of normal, and if above the ULN, must not be clinically significant in the opinion of the Investigator. A subject with laboratory values outside the reference range may be included at the Investigator's discretion if it is considered clinically insignificant, unlikely to introduce additional risk factors and, in their opinion, does not interfere with study procedures;
• 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:
• Abstinence;
• Vasectomized partner (provided that the partner is the sole sexual partner of WOCBP and that the vasectomized partner has received medical assessment of the surgical success);
• Oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation;
• Oral, injectable, or implantable progestogen-only hormone contraception associated with inhibition of ovulation;

You may not qualify if:

• 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:
• Evidence of current SARS-CoV-2 infection (COVID-19) based on testing at screening;
• Documented prior COVID-19 infection in the last 6 months;
• Prior COVID 19 infection with ongoing sequelae (i.e., long-hauler COVID), or history of COVID-19 infection requiring an intensive care unit stay or mechanical ventilation;
• Current or history of the following medical conditions:
• Respiratory disease requiring current medical intervention;
• Hypersensitivity or severe allergic reactions to vaccines or drugs;
• Diagnosis of diabetes mellitus or history of hypo- or hyperglycemia;
• Clinically relevant hypertension;
• History or active diagnosis of renal disease secondary to diabetes, hypertension, vascular disease;
• History of bleeding diathesis or coagulopathy;
• Cardiovascular diseases:
• 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);

Sponsors & Collaborators

• Moleculin Biotech, Inc.: lead

Study Sites (1)

Medicines Evaluation Unit

Manchester, United Kingdom

Location

MeSH Terms

Interventions

3,6-di-O-acetyl-2-deoxy-D-glucopyranose

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 19, 2022
• Study Start: May 11, 2022
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

GB (1)