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A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Inhaled XQ-001 in Healthy Subjects

NCT06918366 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-04-10

No results posted yet for this study

Summary

The primary study objective is to evaluate the safety and tolerability of XQ-001 for inhalation after single and multiple nebulized inhalation administration in healthy Chinese adult subjects.

Conditions

  • Healthy

Interventions

DRUG

Part A - single rising dose 1

Inhaled XQ-001

DRUG

Part A - single rising dose 2

Inhaled XQ-001 or Placebo

DRUG

Part A - single rising dose 3

Inhaled XQ-001 or Placebo

DRUG

Part A - single rising dose 4

Inhaled XQ-001 or Placebo

DRUG

Part A - single rising dose 5

Inhaled XQ-001 or Placebo

DRUG

Part A - single rising dose 6

Inhaled XQ-001 or Placebo

DRUG

Part B - mutiple rising dose 1

Inhaled XQ-001 or Placebo

DRUG

Part B - mutiple rising dose 2

Inhaled XQ-001 or Placebo

Sponsors & Collaborators

  • Brilliant Inspiration Biotherapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-03-31
Completion
2025-05-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06918366 on ClinicalTrials.gov