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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2020-11-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety , tolerability and pharmacokinetics after multiple ascending of HNC042 given to healthy Chinese volunteers, compared to placebo.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

H1N1v Virus Challenge Study in Healthy Subjects

NCT04044352

Influenza

COMPLETED PHASE1

Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) : Multi-centre, Prospective, Randomized Controlled Study

NCT00935194

Influenza

COMPLETED PHASE4

Safety Study of Freeze-dried Live Attenuated Influenza Vaccine for Intranasal Administration in Chinese Adults Aged 3 Years and Older

NCT02665871

Influenza

UNKNOWN PHASE1

Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Chinese Subjects 18 to 59 Years

NCT03344029

Influenza Flu

COMPLETED PHASE4

Study to Assess Safety of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults

NCT01258062

Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HNC042

HNC4042 for injection,freeze-dried powder,multiple ascending doses, Intravenous route

Group Type EXPERIMENTAL

HNC042 for Injection

Intervention Type DRUG

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

Placebo

Placebo, multiple ascending doses, Intravenous route

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Placebo , Intravenous route , multiple ascending doses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HNC042 for Injection

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

Intervention Type DRUG

Placebo Comparator

Placebo , Intravenous route , multiple ascending doses

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent
* Healthy adult male or female volunteers, age 18-65 years，
* BMI between 19-26 kg/m2,and male body weight not less than 50.0kg,female body weight not less than 45.0kg .
* volunteers with normal renal function