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

Guangzhou Henovcom Bioscience Co. Ltd.74 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Paolo B. DePetrillo

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Between screening and 7 days after the last dose

Secondary Outcomes

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

Data from ClinicalTrials.gov

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