NCT06530966

Brief Summary

A multiple ascending dose phase I study of ICP-332 in healthy subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 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

July 23, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2024

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

July 28, 2024

Last Update Submit

April 12, 2026

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (5)

  • Number of participants with Adverse Events (AEs)

    Up to Day 28

  • Number of Participants With Clinically Significant Change in Vital Signs

    Up to Day 28

  • Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)

    Up to Day 28

  • Number of Participants With Clinically Significant Change in Physical Examination

    Up to Day 28

  • Number of Participants With Clinically Significant Change in Clinical Laboratory Values

    Up to Day 28

Study Arms (2)

ICP-332

EXPERIMENTAL
Drug: ICP-332 Tablets

Placebo

PLACEBO COMPARATOR
Drug: ICP-332 Placebo Tablets

Interventions

ICP-332 TabletsDRUG

Eligible patients will receive ICP-332 tablets orally as per the protocol

ICP-332
ICP-332 Placebo TabletsDRUG

Eligible patients will receive ICP-332 placebo tablets orally as per the protocol

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntarily sign the informed consent form
  • Body mass index (BMI) of ≥ 18.5 kg/m2 and \< 30 kg/m2
  • Male or infertile female subjects who are between 18-55 years old (inclusive)

You may not qualify if:

  • Significant current or past acute or chronic disease or condition.
  • A history of tuberculosis or current active/latent infection.
  • With a history of drug or food allergy, or allergy to any of the composition components of the study drug, or allergic disease.
  • Subjects with clinically significant abnormalities in the screening examinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmaron CPC Inc.

Baltimore, Maryland, 21201, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2024

First Posted

July 31, 2024

Study Start

July 23, 2024

Primary Completion

November 8, 2024

Study Completion

November 8, 2024

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

US(1)