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

• Sponsor: Guangzhou Henovcom Bioscience Co. Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03740555
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 4
• Actual Duration (Months): 8.3
• Patients Per Site Per Month: 8.9

Study Details

Study Description

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

• Study Type: Interventional
• 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: Nov 9, 2018
• Actual Primary Completion Date: Jul 19, 2019
• Actual Study Completion Date: Jul 19, 2019

Arms and Interventions

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

Primary Outcome Measures

1. Number of subjects with adverse events [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 [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 [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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Paolo B. DePetrillo	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• Guangzhou Henovcom Bioscience Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guangzhou Henovcom Bioscience Co. Ltd.
• ClinicalTrials.gov Identifier: NCT03740555
• Other Study ID Numbers: HNC042-101
• First Posted: Nov 14, 2018
• Last Update Posted: Sep 19, 2019
• Last Verified: Sep 1, 2019

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

Study Results

No Results Posted as of Sep 19, 2019