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

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ClinicalTrials.gov Identifier: NCT03740555
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Guangzhou Henovcom Bioscience Co. Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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
Estimated Primary Completion Date : March 29, 2019
Estimated Study Completion Date : March 29, 2019

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




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



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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

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


Contacts
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Contact: Yan LIU 86+ 2032039100 yanliu@henovcom.com

Locations
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United States, Maryland
Paolo B. DePetrillo Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: DePetrillo, M.D         
Sponsors and Collaborators
Guangzhou Henovcom Bioscience Co. Ltd.

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Responsible Party: Guangzhou Henovcom Bioscience Co. Ltd.
ClinicalTrials.gov Identifier: NCT03740555     History of Changes
Other Study ID Numbers: HNC042-101
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018

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