A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults

Summary

The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults

Conditions

• Healthy

Interventions

DRUG

ND-003 40mg

Participants receive 40mg ND-003 tablets once.

DRUG

ND-003 placebo 40mg

Participants receive placebo tablet matching to receive 40mg of ND-003.

DRUG

ND-003 80mg

Participants receive 80mg ND-003 tablets once.

DRUG

ND-003 placebo 80mg

Participants receive placebo tablet matching to receive 80mg of ND-003.

DRUG

ND-003 160mg

Participants receive 160mg ND-003 tablets once.

DRUG

ND-003 placebo 160mg

Participants receive placebo tablet matching to receive 160mg of ND-003.

DRUG

ND-003 240mg

Participants receive 240mg ND-003 tablets once.

DRUG

ND-003 placebo 240mg

Participants receive placebo tablet matching to receive 240mg of ND-003.

DRUG

ND-003 300mg

Participants receive 300mg ND-003 tablets once.

DRUG

ND-003 placebo 300mg

Participants receive placebo tablet matching to receive 300mg of ND-003.

DRUG

MAD_ND003_Dose 1

Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.

DRUG

MAD_placebo_Dose 1

Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 1

DRUG

MAD_ND003_Dose 2

Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.

DRUG

MAD_placebo_Dose 2

Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 2

DRUG

MAD_ND003_Dose 3

Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.

DRUG

MAD_ placebo_Dose 3

Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 3

DRUG

Food effect_Cohort 1

Firstly orally administrated ND-003 tablets in fast state and then in fed state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD.

DRUG

Food effect_Cohort 2

Firstly orally administrated ND-003 tablets in fed state and then in fast state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD.

Sponsors & Collaborators

• Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd.

  collaborator UNKNOWN

• Shenzhen NewDEL Biotech, Co., Ltd

  lead INDUSTRY

Principal Investigators

• Shaojun Shi, PhD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-05-09

Primary Completion

2024-12-31

Completion

2025-02-28

Countries

• China

Study Locations