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

Guangzhou Henovcom Bioscience

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo single dose; Drug: Placebo multiple ascending doses; Drug: HNC042 multiple ascending doses; Drug: HNC042 single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03740555

HNC042-101

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 4 patient groups, including a placebo group

HNC042 single dose

Experimental group

Description:

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

Treatment:

Drug: HNC042 single dose

Placebo single dose

Placebo Comparator group

Description:

Placebo single ascending doses , Intravenous route Single dose

Treatment:

Drug: Placebo single dose

HNC042 multiple ascending doses

Experimental group

Description:

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

Treatment:

Drug: HNC042 multiple ascending doses

Placebo, multiple ascending doses

Placebo Comparator group

Description:

Placebo, multiple ascending doses, Intravenous route,

Treatment:

Drug: Placebo multiple ascending doses