InfluenzaPhase 1NCT04603989
A Study of HNC042 in Healthy Chinese Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics
A Phase 1 study testing HNC042 for Injection in people with Influenza, run by Guangzhou Henovcom Bioscience Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety , tolerability and pharmacokinetics after multiple ascending of HNC042 given to healthy Chinese volunteers, compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- HNC042 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 13 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent
- Healthy adult male or female volunteers, age 18-65 years，
- BMI between 19-26 kg/m2,and male body weight not less than 50.0kg,female body weight not less than 45.0kg .
- volunteers with normal renal function
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, Multiple Ascending Doses Study Following Intravenous Administration in Healthy Chinese Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of HNC042
The purpose of this study is to evaluate the safety , tolerability and pharmacokinetics after multiple ascending of HNC042 given to healthy Chinese volunteers, compared to placebo.
- Conditions
- Influenza
- Being tested
- HNC042 for Injection, Placebo Comparator
- Keywords
- Neuraminidase inhibitor
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HNC042 for InjectionDrug
HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, doses: 300mg to 1200mg
Placebo ComparatorDrug
Placebo , Intravenous route , multiple ascending doses
| Study group | Role | What they receive |
|---|---|---|
| HNC042 | Experimental | HNC4042 for injection,freeze-dried powder,multiple ascending doses, Intravenous route Receives: Drug: HNC042 for Injection |
| Placebo | Placebo comparator | Placebo, multiple ascending doses, Intravenous route Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with abnormal vital signs
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal vital signs
Measured: Between screening and 15 days after the last dose
Number of subjects with abnormal laboratory
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal laboratory
Measured: Between screening and 15 days after the last dose
Number of subjects with abnormal electrocardiogram
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of abnormal electrocardiogram
Measured: Between screening and 15 days after the last dose
Number of subjects with abnormal physical examination
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of abnormal physical examination
Measured: Between screening and 15 days after the last dose
Number of subjects with adverse reactions at injection site
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of adverse reactions at injection site
Measured: Between screening and 15 days after the last dose
Number of subjects with adverse events
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of adverse events
Measured: Between screening and 15 days after the last dose
Number of subjects with clinical symptoms
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of clinical symptoms
Measured: Between screening and 15 days after the last dose
Secondary outcomes (8)
Pharmacokinetics of HNC042 in plasma: Cmax
To characterize the pharmacokinetic parameters：Cmax of HNC042 after the the first day administer .
Measured: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma: Tmax
To characterize the pharmacokinetic parameters：Tmax of HNC042 after the the first day administer .
Measured: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma: AUC0-last
To characterize the pharmacokinetic parameters：AUC0-last of HNC042 after the the first day administer .
Measured: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma: AUC0-∞
To characterize the pharmacokinetic parameters： AUC0-∞ of HNC042 after the the first day administer .
Measured: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma:t1/2
To characterize the pharmacokinetic parameters： t1/2 of HNC042 after the the first day administer .
Measured: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma:MRT
To characterize the pharmacokinetic parameters： MRT of HNC042 after the the first day administer .
Measured: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma:CL
To characterize the pharmacokinetic parameters：CL of HNC042 after the the first day administer .
Measured: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma:Vd
To characterize the pharmacokinetic parameters：Vd of HNC042 after the the first day administer .
Measured: Between Day 1 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Aug 2020
- Primary completion13 Nov 2020
- Study completion13 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Lu Xiang, MD, Principal investigator, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603989
- Sponsor's protocol ID
- HNC042-102
- Other IDs
- ZBD1042-CSP01
- Status last verified
- Aug 2020
- First submitted
- 13 Oct 2020
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Multiple Ascending Doses Study Following Intravenous Administration in Healthy Chinese Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of HNC042
- ClinicalTrials.gov ID
- NCT04603989
- Acronym / sponsor ID
- HNC042-102
- Conditions
- Influenza
- Keywords
- Neuraminidase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd.
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 27 Oct 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 study is to evaluate the safety , tolerability and pharmacokinetics after multiple ascending of HNC042 given to healthy Chinese volunteers, compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HNC042 | Experimental | Drug: HNC042 for InjectionHNC4042 for injection,freeze-dried powder,multiple ascending doses, Intravenous route |
| Placebo | Placebo comparator | Drug: Placebo ComparatorPlacebo, multiple ascending doses, Intravenous route |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent
- Healthy adult male or female volunteers, age 18-65 years，
- BMI between 19-26 kg/m2,and male body weight not less than 50.0kg,female body weight not less than 45.0kg .
- volunteers with normal renal function
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 |
|---|---|---|
| HNC042 for InjectionHNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, doses: 300mg to 1200mg | Drug | HNC042 |
| Placebo ComparatorPlacebo , Intravenous route , multiple ascending doses | Drug | Placebo |
Primary outcome
Number of subjects with abnormal vital signs
Time frame: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal vital signs
Number of subjects with abnormal laboratory
Time frame: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Chinese subjects in terms of abnormal laboratory
Number of subjects with abnormal electrocardiogram
Time frame: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of abnormal electrocardiogram
Number of subjects with abnormal physical examination
Time frame: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of abnormal physical examination
Number of subjects with adverse reactions at injection site
Time frame: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of adverse reactions at injection site
Number of subjects with adverse events
Time frame: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of adverse events
Number of subjects with clinical symptoms
Time frame: Between screening and 15 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after multiple intravenous dose in healthy Cjinese subjects in terms of clinical symptoms
8 secondary outcomes
Pharmacokinetics of HNC042 in plasma: Cmax
Time frame: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma: Tmax
Time frame: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma: AUC0-last
Time frame: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma: AUC0-∞
Time frame: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma:t1/2
Time frame: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma:MRT
Time frame: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma:CL
Time frame: Between Day 1 to 7 days
Pharmacokinetics of HNC042 in plasma:Vd
Time frame: Between Day 1 to 7 days
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 23 Feb 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.
Lu Xiang, MD principal investigator
Nanjing Medical University
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 HNC042 for Injection in people with Influenza, run by Guangzhou Henovcom Bioscience Co. Ltd. at 1 site in China.
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 4 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 23 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 China. 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 abnormal vital signs (time frame: Between screening and 15 days after the last dose). The study lists 7 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 23 Feb 2023.