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A Study of HNC042 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03740555
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Guangzhou Henovcom Bioscience Co. Ltd.

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: HNC042 single dose Drug: Placebo single dose Drug: HNC042 multiple ascending doses Drug: Placebo multiple ascending doses Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : November 9, 2018
Actual Primary Completion Date : July 19, 2019
Actual Study Completion Date : July 19, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: HNC042 single dose
HNC042,freeze-dried powder,single ascending doses Single dose,
 Drug: HNC042 single dose
HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg
Placebo Comparator: Placebo single dose
Placebo single ascending doses , Intravenous route Single dose
 Drug: Placebo single dose
Placebo single ascending doses , Intravenous route Single dose, matching placebo
Experimental: HNC042 multiple ascending doses
HNC042,freeze-dried powder,multiple ascending doses, Intravenous route
 Drug: HNC042 multiple ascending doses
HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, anticipated doses: 300mg to 1200mg
Placebo Comparator: Placebo, multiple ascending doses
Placebo, multiple ascending doses, Intravenous route,
 Drug: Placebo multiple ascending doses
Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. The amount of HNC042 in plasma [ Time Frame: Between Day 1 predose and 24 hours after the (last) dose ]
    To characterize the amount of HNC042 in plasma over time - pharmacokinetics (PK) - after a single and multiple intravenous dose in healthy subjects

  2. The amount of HNC042 in urine [ Time Frame: Between Day 1 predose and 24 hours after the (last) dose ]
    To characterize the amount of HNC042 in urine over time - pharmacokinetics (PK) - after a single and multiple intravenous dose in healthy subjects


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer, age 18-56 years
  • BMI between 18-34 kg/m2,and body weight not less than 50.0kg.

Exclusion Criteria:

  • Any condition that might interfere with the procedures or tests in this study
  • Drug or alcohol abuse
  • Smoking
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740555


Locations
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United States, Maryland
Paolo B. DePetrillo
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Guangzhou Henovcom Bioscience Co. Ltd.
More Information
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Responsible Party: Guangzhou Henovcom Bioscience Co. Ltd.
ClinicalTrials.gov Identifier: NCT03740555    
Other Study ID Numbers: HNC042-101
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No