NCT06428903

Brief Summary

Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food. The purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2024

Completed
Last Updated

January 20, 2025

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 19, 2024

Last Update Submit

January 17, 2025

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

  • ADC189 Granules

    ADC189 plasma exposure, area under the concentration-time curve

    15 days

  • ADC189 Tablet

    ADC189 plasma exposure, area under the concentration-time curve

    15 days

  • ADC189 Ultra high dose

    Single dose of 180mg ADC189 tablet plasma exposure, area under the concentration-time curve

    15 days

Study Arms (3)

ADC189 tablet Group A

EXPERIMENTAL

16 patients.

Drug: ADC189 tabletDrug: ADC189 granules

ADC189 granules Group B

EXPERIMENTAL

16 patients.

Drug: ADC189 tabletDrug: ADC189 granules

ADC189 180mg Group

EXPERIMENTAL

8 patients.

Drug: ADC189 180mg

Interventions

ADC189 tabletDRUG

ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study)

ADC189 granules Group BADC189 tablet Group A
ADC189 granulesDRUG

ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)

ADC189 granules Group BADC189 tablet Group A
ADC189 180mgDRUG

ADC189 tablet, 180 mg, single oral dose. (Part 2 study)

ADC189 180mg Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Healthy male subjects aged 18-45 years old
  • \. Male subjects weight over 50 kg

You may not qualify if:

  • \. Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
  • \. Have a history of drug abuse in the past five years or use drugs in the three months prior to screening
  • \. Blood donation or blood loss \> 400 mL in 3 months before screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhao Wei

Jinan, Shang Dong, 250000, China

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2024

First Posted

May 24, 2024

Study Start

March 12, 2024

Primary Completion

September 22, 2024

Study Completion

September 22, 2024

Last Updated

January 20, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)