Healthy VolunteerPhase 1NCT05195723
Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers
A Phase 1 study testing WP1122 in people with Healthy Volunteer, run by Moleculin Biotech, Inc. at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- WP1122
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 May 2022to 24 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
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- 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;
- Any effective intrauterine device/levonorgestrel intrauterine system;
- Female sterilization by tubal occlusion;
- WOCBP must agree to use a highly effective method of birth control, as defined above, from the time of signing the ICF, throughout the study duration and until 30 days after the last dose of study drug. Volunteers must have a negative serum pregnancy test result at screening; *WOCBP are defined as women who are NOT permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), and who are NOT post-menopausal. Women will be considered post-menopausal if they have been amenorrhoeic for at least 12 months without an alternative medical cause and follicle stimulating hormone (FSH) > 40 IU/mL.
- 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.
Who cannot join
- 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;
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- 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:
- 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:
- Primary immunodeficiencies;
- Long-term use (≥7 days) of oral or parenteral glucocorticoids;
- Current or anticipated use of disease-modifying doses of antirheumatic drugs and biologic disease-modifying drugs, and no use of such drugs within the last 12 months;
- History of solid organ or bone marrow transplantation;
- Prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune diseases;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Overlapping Single and Multiple Ascending Dose Escalation Study of WP1122 to Establish Maximum Tolerated Dose and Evaluate Pharmacokinetics
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
- Being tested
- WP1122, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WP1122Drug
Oral solution
PlaceboDrug
Oral solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 10 weeks
Secondary outcomes (2)
Maximum Plasma Concentration (Cmax) in Single Ascending Dose
To examine the activity of WP1122 in the body following a single PO dose of WP1122.
Measured: 5 weeks
Maximum Plasma Concentration (Cmax) in Multiple Ascending Dose
To examine the activity of WP1122 in the body following 7 days of q12h PO dosing.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start11 May 2022
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moleculin Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195723
- Sponsor's protocol ID
- MB-301
- Status last verified
- Feb 2023
- First submitted
- 29 Nov 2021
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Overlapping Single and Multiple Ascending Dose Escalation Study of WP1122 to Establish Maximum Tolerated Dose and Evaluate Pharmacokinetics
- ClinicalTrials.gov ID
- NCT05195723
- Acronym / sponsor ID
- MB-301
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Moleculin Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WP1122 | Experimental | Drug: WP1122Each 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 | Drug: PlaceboEach 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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;
Key exclusion criteria (33 listed)
- 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:
- Immunosuppression as a result of underlying illness or treatment including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WP1122Oral solution | Drug | WP1122 |
| PlaceboOral solution | Drug | Placebo |
Primary outcome
Safety in Single Ascending Dose (SAD)
Time frame: 5 weeks
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
Safety in Multiple Ascending Dose (MAD)
Time frame: 10 weeks
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).
2 secondary outcomes
Maximum Plasma Concentration (Cmax) in Single Ascending Dose
Time frame: 5 weeks
Maximum Plasma Concentration (Cmax) in Multiple Ascending Dose
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WP1122 in people with Healthy Volunteer, run by Moleculin Biotech, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety in Single Ascending Dose (SAD) (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.