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

NCT ID: NCT03740555

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2019-07-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HNC042 single dose

HNC042,freeze-dried powder,single ascending doses Single dose,

Group Type EXPERIMENTAL

HNC042 single dose

Intervention Type DRUG

HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg

Placebo single dose

Placebo single ascending doses , Intravenous route Single dose

Group Type PLACEBO_COMPARATOR

Placebo single dose

Intervention Type DRUG

Placebo single ascending doses , Intravenous route Single dose, matching placebo

HNC042 multiple ascending doses

HNC042,freeze-dried powder,multiple ascending doses, Intravenous route

Group Type EXPERIMENTAL

HNC042 multiple ascending doses

Intervention Type DRUG

HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, anticipated doses: 300mg to 1200mg

Placebo, multiple ascending doses

Placebo, multiple ascending doses, Intravenous route,

Group Type PLACEBO_COMPARATOR

Placebo multiple ascending doses

Intervention Type DRUG

Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo

Interventions

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HNC042 single dose

HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg

Intervention Type DRUG

Placebo single dose

Placebo single ascending doses , Intravenous route Single dose, matching placebo

Intervention Type 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

Intervention Type DRUG

Placebo multiple ascending doses

Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou Henovcom Bioscience Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Paolo B. DePetrillo

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HNC042-101

Identifier Type: -

Identifier Source: org_study_id

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