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A Phase 1 Study of FZ008-145 in Healthy Subjects.

NCT06685809 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-02-12

No results posted yet for this study

Summary

The study will be conducted in 5 parts: Part A (single ascending dose \[SAD\] in solution formulation), Part C (food effect \[FE\]), Part D (cold pressor test \[CPT\] to evaluate pain tolerance following single dose), and Part E (multiple ascending dose \[MAD\] in tablet formulation).

Conditions

  • Healthy

Interventions

DRUG

FZ008-145 solution

Dose formulation- Oral solution

DRUG

FZ008-145 Tablet

Dose formulation- Oral tablet

DRUG

Placebo

Dose formulation- Matching doses

Sponsors & Collaborators

  • Guangzhou Fermion Technology Co., LTD

    lead INDUSTRY

Principal Investigators

  • Shiqun Zhang · Guangzhou Fermion Technology Co., LTD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2026-04-01
Completion
2026-06-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT06685809 on ClinicalTrials.gov