A Study of HNC664 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics

NCT ID: NCT04504448

Last Updated: 2022-08-26

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-11

Study Completion Date

2021-07-13

Brief Summary

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The purpose of this First-in-Human study is to evaluate the safety , tolerability,PK and PD after single ascending of HNC664 given to healthy subjects, compared to placebo. Also, food effect will be evaluated.

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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HNC664 capsules

HNC664 capsules,single ascending doses Single dose

Group Type EXPERIMENTAL

HNC664 capsules Single dose

Intervention Type DRUG

HNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg

HNC664 placebos

HNC664 placebos,single ascending doses Single dose

Group Type PLACEBO_COMPARATOR

HNC664 placebos Single dose

Intervention Type DRUG

HNC664 placebos single ascending doses,PO,Single dose, matching placebo

HNC664 capsules FED

HNC664 capsules,food effect,Single dose

Group Type EXPERIMENTAL

HNC664 capsules FED

Intervention Type DRUG

HNC664 capsules,single doses Single dose, PO,food effect(dosage will be based on data from SAD cohorts and decided by the IDRC)

Interventions

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HNC664 capsules Single dose

HNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg

Intervention Type DRUG

HNC664 placebos Single dose

HNC664 placebos single ascending doses,PO,Single dose, matching placebo

Intervention Type DRUG

HNC664 capsules FED

HNC664 capsules,single doses Single dose, PO,food effect(dosage will be based on data from SAD cohorts and decided by the IDRC)

Intervention Type DRUG

Other Intervention Names

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HNC664 capsules HNC664 placebos HNC664 capsules

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteer, age 18-65 years
* BMI between 18-32 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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Pharmaron

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HNC664-101

Identifier Type: -

Identifier Source: org_study_id

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