Healthy VolunteersPhase 1NCT04220801
A Study of Orally Administered ZM-H1505R to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Doses in Healthy Participants
A Phase 1 study testing ZM-H1505R in people with Healthy Volunteers, run by Shanghai Zhimeng Biopharma, Inc. at 1 site in United States.
Trial summary
ZM-H1505R is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B. The purpose of this study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also test how the study drug is taken up and eliminated by the body. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ZM-H1505R
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2020to 18 Nov 2020
- 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
- 1. Are capable of giving informed consent and complying with study procedures;
- 2. Are between the ages of 18 and 55 years, inclusive;
- 3. Female subjects have a negative pregnancy test results at screening and Day -1, and meet one of the following criteria:
- Using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
- Surgically sterile for at least 3 months prior to screening by one of the following means:
- Bilateral tubal ligation
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- Bilateral salpingectomy (with or without oophorectomy)
- Surgical hysterectomy
- Bilateral oophorectomy (with or without hysterectomy)
- Postmenopausal, defined as the following:
- Last menstrual period greater than 12 months prior to screening
- Postmenopausal status confirmed by serum FSH and estradiol levels at screening;
- 4. Considered healthy by the Investigator, based on subject's reported medical history, full PE, clinical laboratory tests, 12-lead ECG, and vital signs;
- 5. Normal liver function (AST/ALT < 1.5x ULN) and normal renal function (eGFR> 60mL/min/1.73 m2) as determined by Investigator following review of clinical laboratory test results;
- 6. Non-smoker and no nicotine containing products (including e-cigarettes) within 6 months;
- -- 7. Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
- 8. Willing and able to adhere to study restrictions and to be confined at the clinical research center.
- 9. Male subjects with female partners of child bearing potential must agree to use condoms for the duration of the study and until 12 weeks after dosing with the study drug and must refrain from donating sperm for this same period.
Who cannot join
- 1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- 2. Reported or suspected malignancy;
- 3. Reported history of pancreatitis or gall stones;
- 4. Reported history of unexplained syncope, symptomatic hypotension or hypoglycemia;
- 5. Reported family history of long QTc syndrome;
- 6. Reported history of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
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- 7. Poor venous access;
- 8. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
- 9. Donated or lost >500ml of blood in the previous 3 months;
- 10. Taken an investigational drug or participated in a clinical trial within 3 months (or 5 half-lives), whichever is longer;
- 11. Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug;
- 12. Hospital admission or major surgery within 6 months prior to screening;
- 13. A reported history of prescription drug abuse, or illicit drug use within 9 months prior to screening;
- 14. A reported history of alcohol abuse according to medical history within 9 months prior to screening;
- 15. A positive screen for alcohol, drugs of abuse at screening or Day -1;
- 16. An unwillingness or inability to comply with food and beverage restrictions during study participation;
- 17. Use of over-the-counter (OTC) medication within 7 days, and herbal supplements (including St John's Wort, herbal teas, garlic extracts) within 7 days prior to dosing (Note: Use of acetaminophen at < 2 g/day is permitted until 24 hours prior to dosing)
- 18. Any condition or finding that in the Investigators opinion would put the subject or study conduct at risk if the subject were to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services
Secaucus, New Jersey, 07094
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Dose (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZM-H1505R
ZM-H1505R is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.
The purpose of this study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also test how the study drug is taken up and eliminated by the body. An additional part of the study is to look at how this could be changed by giving the study drug with food.
- Conditions
- Healthy Volunteers
- Being tested
- ZM-H1505R
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZM-H1505RDrug
Single oral doses of 300, 450, 600, 750, and 900 mg of ZM-H1505R or placebo and multiple oral doses of 450, 600, and 750 mg of ZM-H1505R or placebo will be administered in a fasted state, or in the case of Cohort 3 (Part 1), a second dose of 600 mg will be administered in the fed state. During each SAD and MAD dosing period, 2 subjects in each cohort will receive placebo instead of ZM-H1505R. The dose levels may be adjusted based on the safety and tolerability obtained from the previous cohort.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 of Part 1 (SAD) | Experimental | 300 mg ZM-H1505R or placebo Receives: Drug: ZM-H1505R |
| Cohort 2 of Part 1(SAD) | Experimental | 450 mg ZM-H1505R or placebo Receives: Drug: ZM-H1505R |
| Cohort 3 of Part 1(SAD) | Experimental | 150 mg ZM-H1505R or placebo (2 periods) Receives: Drug: ZM-H1505R |
| Cohort 4 of Part 1(SAD) | Experimental | 75 mg ZM-H1505R or placebo Receives: Drug: ZM-H1505R |
| Cohort 5 of Part 1(SAD) | Experimental | 25 mg ZM-H1505R or placebo Receives: Drug: ZM-H1505R |
| Cohort 1 of Part 2 (MAD) | Experimental | 75 mg ZM-H1505R or placebo Receives: Drug: ZM-H1505R |
| Cohort 2 of Part 2 (MAD) | Experimental | 150 mg ZM-H1505R or placebo Receives: Drug: ZM-H1505R |
| Cohort 3 of Part 2 (MAD) | Experimental | 300 mg ZM-H1505R or placebo Receives: Drug: ZM-H1505R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively.
Safety evaluations will be based on the incidence, intensity, and relatedness of AEs
Measured: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2
Number of Participants With Abnormal Physical Examinations
Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively.
Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes in subject PE findings
Measured: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2
Number of Participants With Abnormal Vital Signs
Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively.
Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes in subject vital signs
Measured: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2
Number of Participants With Clinically Significant Laboratory Findings
Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively.
Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes in subject clinical laboratory results
Measured: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2
Number of Participants With Abnormal ECGs
Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively.
Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes in subject ECGs.
Measured: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start17 Feb 2020
- Primary completion18 Nov 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhimeng Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Tracey, MD., Principal investigator, Frontage Clinical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220801
- Sponsor's protocol ID
- ZM-H1505R-101
- Status last verified
- Mar 2021
- First submitted
- 23 Dec 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang X, Hua B, Liu G, Xia T, Deng A, Lu H, Guo R, Wang Z, Liang B, Chen H, Jin Q, Zhang Z. Safety, Tolerability, and Pharmacokinetics of a Novel Human Hepatitis B Virus Capsid Assembly Modulator Canocapavir: A Randomized First-in-Human Study. Gastro Hep Adv. 2023 Jan 7;2(4):524-531. doi: 10.1016/j.gastha.2023.01.001. eCollection 2023.
PubMed 39132049
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Dose (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZM-H1505R
- ClinicalTrials.gov ID
- NCT04220801
- Acronym / sponsor ID
- ZM-H1505R-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shanghai Zhimeng Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 7 Jan 2020 (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.
ZM-H1505R is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.
The purpose of this study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also test how the study drug is taken up and eliminated by the body. An additional part of the study is to look at how this could be changed by giving the study drug with food.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 of Part 1 (SAD) | Experimental | Drug: ZM-H1505R300 mg ZM-H1505R or placebo |
| Cohort 2 of Part 1(SAD) | Experimental | Drug: ZM-H1505R450 mg ZM-H1505R or placebo |
| Cohort 3 of Part 1(SAD) | Experimental | Drug: ZM-H1505R150 mg ZM-H1505R or placebo (2 periods) |
| Cohort 4 of Part 1(SAD) | Experimental | Drug: ZM-H1505R75 mg ZM-H1505R or placebo |
| Cohort 5 of Part 1(SAD) | Experimental | Drug: ZM-H1505R25 mg ZM-H1505R or placebo |
| Cohort 1 of Part 2 (MAD) | Experimental | Drug: ZM-H1505R75 mg ZM-H1505R or placebo |
| Cohort 2 of Part 2 (MAD) | Experimental | Drug: ZM-H1505R150 mg ZM-H1505R or placebo |
| Cohort 3 of Part 2 (MAD) | Experimental | Drug: ZM-H1505R300 mg ZM-H1505R or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 1. Are capable of giving informed consent and complying with study procedures;
- 2. Are between the ages of 18 and 55 years, inclusive;
- 3. Female subjects have a negative pregnancy test results at screening and Day -1, and meet one of the following criteria:
- 4. Considered healthy by the Investigator, based on subject's reported medical history, full PE, clinical laboratory tests, 12-lead ECG, and vital signs;
- 5. Normal liver function (AST/ALT < 1.5x ULN) and normal renal function (eGFR> 60mL/min/1.73 m2) as determined by Investigator following review of clinical laboratory test results;
Key exclusion criteria (18 listed)
- 1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- 2. Reported or suspected malignancy;
- 3. Reported history of pancreatitis or gall stones;
- 4. Reported history of unexplained syncope, symptomatic hypotension or hypoglycemia;
- 5. Reported family history of long QTc syndrome;
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 |
|---|---|---|
| ZM-H1505RSingle oral doses of 300, 450, 600, 750, and 900 mg of ZM-H1505R or placebo and multiple oral doses of 450, 600, and 750 mg of ZM-H1505R or placebo will be administered in a fasted state, or in the case of Cohort 3 (Part 1), a second dose of 600 mg will be administered in the fed state. During each SAD and MAD dosing period, 2 subjects in each cohort will receive placebo instead of ZM-H1505R. The dose levels may be adjusted based on the safety and tolerability obtained from the previous cohort. | Drug | Cohort 1 of Part 1 (SAD), Cohort 1 of Part 2 (MAD), Cohort 2 of Part 1(SAD), Cohort 2 of Part 2 (MAD), Cohort 3 of Part 1(SAD), Cohort 3 of Part 2 (MAD), Cohort 4 of Part 1(SAD), Cohort 5 of Part 1(SAD) |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Time frame: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2
Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively. Safety evaluations will be based on the incidence, intensity, and relatedness of AEs
Number of Participants With Abnormal Physical Examinations
Time frame: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2
Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively. Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes in subject PE findings
Number of Participants With Abnormal Vital Signs
Time frame: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2
Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively. Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes in subject vital signs
Number of Participants With Clinically Significant Laboratory Findings
Time frame: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2
Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively. Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes in subject clinical laboratory results
Number of Participants With Abnormal ECGs
Time frame: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2
Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively. Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes in subject ECGs.
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 28 Apr 2021.
- Derived from this study: PubMed 39132049Jiang X, Hua B, Liu G, Xia T, Deng A, Lu H, Guo R, Wang Z, Liang B, Chen H, Jin Q, Zhang Z. Safety, Tolerability, and Pharmacokinetics of a Novel Human Hepatitis B Virus Capsid Assembly Modulator Canocapavir: A Randomized First-in-Human Study. Gastro Hep Adv. 2023 Jan 7;2(4):524-531. doi: 10.1016/j.gastha.2023.01.001. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Gregory Tracey, MD. principal investigator
Frontage Clinical Services, Inc.
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 ZM-H1505R in people with Healthy Volunteers, run by Shanghai Zhimeng Biopharma, Inc. at 1 site in United States.
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 18 inclusion and 18 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 28 Apr 2021. 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 States. 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. 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?
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events (time frame: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04220801, which also lists 1 linked publication.
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 28 Apr 2021.