NCT06360874

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

Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Food Effect of ND-003 Tablets in Healthy Adult Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Shenzhen NewDEL Biotech, Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is a Phase 1, randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability and Pharmacokinetic of of ND-003 in healthy adults volunteers, and then evaluate food effects. The study will be conducted in three parts: Part A-Single ascending dose (SAD) , Part B-Multiple ascending dose (MAD) and Part C-Food Effect. Each subject will be enrolled in only one cohort of either Parts A or B or C of the study, to receive only one dose regimen during the study.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-09
• Primary completion: 2024-12-01
• Completion: 2025-02-01
• First posted: 2024-04-11
• Last updated: 2024-05-30

Locations

1 site across 1 country: China