HealthyPhase 1NCT04504448
A Study of HNC664 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics
A Phase 1 study testing HNC664 capsules Single dose and HNC664 capsules FED in people with Healthy, run by Guangzhou Henovcom Bioscience Co. Ltd. at 1 site in United States.
Trial summary
The purpose of this First-in-Human study is to evaluate the safety , tolerability，PK and PD after single ascending of HNC664 given to healthy subjects, compared to placebo. Also, food effect will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HNC664 capsules Single dose and HNC664 capsules FED
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2020to 13 Jul 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer, age 18-65 years
- BMI between 18-32 kg/m2,and body weight not less than 50.0kg.
Who cannot join
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Doses (SAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of HNC664
The purpose of this First-in-Human study is to evaluate the safety , tolerability，PK and PD after single ascending of HNC664 given to healthy subjects, compared to placebo. Also, food effect will be evaluated.
- Conditions
- Healthy
- Being tested
- HNC664 capsules Single dose, HNC664 placebos Single dose, HNC664 capsules FED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HNC664 capsules Single doseDrug
Also called HNC664 capsules
HNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg
HNC664 placebos Single doseDrug
Also called HNC664 placebos
HNC664 placebos single ascending doses,PO,Single dose, matching placebo
HNC664 capsules FEDDrug
Also called HNC664 capsules
HNC664 capsules,single doses Single dose, PO,food effect（dosage will be based on data from SAD cohorts and decided by the IDRC）
| Study group | Role | What they receive |
|---|---|---|
| HNC664 capsules | Experimental | HNC664 capsules,single ascending doses Single dose Receives: Drug: HNC664 capsules Single dose |
| HNC664 placebos | Placebo comparator | HNC664 placebos,single ascending doses Single dose Receives: Drug: HNC664 placebos Single dose |
| HNC664 capsules FED | Experimental | HNC664 capsules,food effect,Single dose Receives: Drug: HNC664 capsules FED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events and concomitant medications
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of AEs and CMs.
Measured: Between screening and 7-9 days after the last dose
Number of subjects with vital sign measurements
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal vital signs
Measured: Between screening and 7-9 days after the last dose
Number of subjects with clinical laboratory test results
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal clinical laboratory test results
Measured: Between screening and 7-9 days after the last dose
Number of subjects with 12-lead ECGs
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal 12-lead ECGs
Measured: Between screening and 7-9 days after the last dose
Number of subjects with physical examinations
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal physical examinations
Measured: Between screening and 7-9 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start11 Aug 2020
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504448
- Sponsor's protocol ID
- HNC664-101
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2020
- Last updated
- 26 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Doses (SAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of HNC664
- ClinicalTrials.gov ID
- NCT04504448
- Acronym / sponsor ID
- HNC664-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 7 Aug 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.
The purpose of this First-in-Human study is to evaluate the safety , tolerability，PK and PD after single ascending of HNC664 given to healthy subjects, compared to placebo. Also, food effect will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HNC664 capsules | Experimental | Drug: HNC664 capsules Single doseHNC664 capsules,single ascending doses Single dose |
| HNC664 placebos | Placebo comparator | Drug: HNC664 placebos Single doseHNC664 placebos,single ascending doses Single dose |
| HNC664 capsules FED | Experimental | Drug: HNC664 capsules FEDHNC664 capsules,food effect,Single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteer, age 18-65 years
- BMI between 18-32 kg/m2,and body weight not less than 50.0kg.
Key exclusion criteria (3 listed)
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
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 |
|---|---|---|
| HNC664 capsules Single doseAlso: HNC664 capsulesHNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg | Drug | HNC664 capsules |
| HNC664 placebos Single doseAlso: HNC664 placebosHNC664 placebos single ascending doses,PO,Single dose, matching placebo | Drug | HNC664 placebos |
| HNC664 capsules FEDAlso: HNC664 capsulesHNC664 capsules,single doses Single dose, PO,food effect（dosage will be based on data from SAD cohorts and decided by the IDRC） | Drug | HNC664 capsules FED |
Primary outcome
Number of subjects with adverse events and concomitant medications
Time frame: Between screening and 7-9 days after the last dose
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of AEs and CMs.
Number of subjects with vital sign measurements
Time frame: Between screening and 7-9 days after the last dose
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal vital signs
Number of subjects with clinical laboratory test results
Time frame: Between screening and 7-9 days after the last dose
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal clinical laboratory test results
Number of subjects with 12-lead ECGs
Time frame: Between screening and 7-9 days after the last dose
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal 12-lead ECGs
Number of subjects with physical examinations
Time frame: Between screening and 7-9 days after the last dose
To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal physical examinations
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 26 Aug 2022.
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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 HNC664 capsules Single dose and HNC664 capsules FED in people with Healthy, run by Guangzhou Henovcom Bioscience Co. Ltd. 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 2 inclusion and 3 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 26 Aug 2022. 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. 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?
Number of subjects with adverse events and concomitant medications (time frame: Between screening and 7-9 days after the last dose). 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?
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 26 Aug 2022.