HealthyPhase 1NCT03740555
A Study of HNC042 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics.
A Phase 1 study testing HNC042 single dose and HNC042 multiple ascending doses 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 and pharmacokinetics after single ascending of HNC042 given to healthy subjects, 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
- Healthy
- What is being tested?
- HNC042 single dose and HNC042 multiple ascending doses
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 19 Jul 2019
- 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 18-56 years
- BMI between 18-34 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 and Multiple Ascending Doses (SAD/MAD) Study Following Intravenous Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of HNC042.
The purpose of this First-in-Human study is to evaluate the safety , tolerability and pharmacokinetics after single ascending of HNC042 given to healthy subjects, compared to placebo. Also, the safety , tolerability and pharmacokinetics of multiple ascending of HNC042 given to healthy subjects daily for 7 days compared to placebo , will be evaluated.
- Conditions
- Healthy
- Being tested
- HNC042 single dose, Placebo single dose, HNC042 multiple ascending doses, Placebo multiple ascending doses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HNC042 single doseDrug
HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg
Placebo single doseDrug
Placebo single ascending doses , Intravenous route Single dose, matching placebo
HNC042 multiple ascending dosesDrug
HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, anticipated doses: 300mg to 1200mg
Placebo multiple ascending dosesDrug
Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo
| Study group | Role | What they receive |
|---|---|---|
| HNC042 single dose | Experimental | HNC042,freeze-dried powder,single ascending doses Single dose, Receives: Drug: HNC042 single dose |
| Placebo single dose | Placebo comparator | Placebo single ascending doses , Intravenous route Single dose Receives: Drug: Placebo single dose |
| HNC042 multiple ascending doses | Experimental | HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Receives: Drug: HNC042 multiple ascending doses |
| Placebo, multiple ascending doses | Placebo comparator | Placebo, multiple ascending doses, Intravenous route, Receives: Drug: Placebo multiple ascending doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of adverse events
Measured: Between screening and 7 days after the last dose
Number of subjects with abnormal laboratory
To evaluate the safety and tolerability of HNC042 in comparison with placebo after single and multiple intravenous dose in healthy subjects in terms of abnormal laboratory
Measured: Between screening and 7days after the last dose
Number of subjects with abnormal electrocardiogram
To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal electrocardiogram
Measured: Between screening and 7 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 a single and multiple intravenous dose in healthy subjects in terms of abnormal physical examination
Measured: Between screening and 7 days after the last dose
Number of subjects with abnormal vital signs
To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal vital signs
Measured: Between screening and 7 days after the last dose
Secondary outcomes (2)
The amount of HNC042 in plasma
To characterize the amount of HNC042 in plasma over time - pharmacokinetics (PK) - after a single and multiple intravenous dose in healthy subjects
Measured: Between Day 1 predose and 24 hours after the (last) dose
The amount of HNC042 in urine
To characterize the amount of HNC042 in urine over time - pharmacokinetics (PK) - after a single and multiple intravenous dose in healthy subjects
Measured: Between Day 1 predose and 24 hours 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 posted14 Nov 2018
- Study start9 Nov 2018
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
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
- 74 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
- NCT03740555
- Sponsor's protocol ID
- HNC042-101
- Status last verified
- Sep 2019
- First submitted
- 9 Nov 2018
- Last updated
- 19 Sep 2019
- 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 19 Sep 2019. 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 and Multiple Ascending Doses (SAD/MAD) Study Following Intravenous Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of HNC042.
- ClinicalTrials.gov ID
- NCT03740555
- Acronym / sponsor ID
- HNC042-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 14 Nov 2018 (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 and pharmacokinetics after single ascending of HNC042 given to healthy subjects, compared to placebo. Also, the safety , tolerability and pharmacokinetics of multiple ascending of HNC042 given to healthy subjects daily for 7 days compared to placebo , 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
- 4
| Arm | Type | Receives |
|---|---|---|
| HNC042 single dose | Experimental | Drug: HNC042 single doseHNC042,freeze-dried powder,single ascending doses Single dose, |
| Placebo single dose | Placebo comparator | Drug: Placebo single dosePlacebo single ascending doses , Intravenous route Single dose |
| HNC042 multiple ascending doses | Experimental | Drug: HNC042 multiple ascending dosesHNC042,freeze-dried powder,multiple ascending doses, Intravenous route |
| Placebo, multiple ascending doses | Placebo comparator | Drug: Placebo multiple ascending dosesPlacebo, 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 (2 listed)
- Healthy volunteer, age 18-56 years
- BMI between 18-34 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 |
|---|---|---|
| HNC042 single doseHNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg | Drug | HNC042 single dose |
| Placebo single dosePlacebo single ascending doses , Intravenous route Single dose, matching placebo | Drug | Placebo single dose |
| HNC042 multiple ascending dosesHNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, anticipated doses: 300mg to 1200mg | Drug | HNC042 multiple ascending doses |
| Placebo multiple ascending dosesPlacebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo | Drug | Placebo, multiple ascending doses |
Primary outcome
Number of subjects with adverse events
Time frame: Between screening and 7 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of adverse events
Number of subjects with abnormal laboratory
Time frame: Between screening and 7days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after single and multiple intravenous dose in healthy subjects in terms of abnormal laboratory
Number of subjects with abnormal electrocardiogram
Time frame: Between screening and 7 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal electrocardiogram
Number of subjects with abnormal physical examination
Time frame: Between screening and 7 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal physical examination
Number of subjects with abnormal vital signs
Time frame: Between screening and 7 days after the last dose
To evaluate the safety and tolerability of HNC042 in comparison with placebo after a single and multiple intravenous dose in healthy subjects in terms of abnormal vital signs
2 secondary outcomes
The amount of HNC042 in plasma
Time frame: Between Day 1 predose and 24 hours after the (last) dose
The amount of HNC042 in urine
Time frame: Between Day 1 predose and 24 hours after the (last) dose
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 19 Sep 2019.
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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 HNC042 single dose and HNC042 multiple ascending doses 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 19 Sep 2019. 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 (time frame: Between screening and 7 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 19 Sep 2019.