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A phase I clinical trial for evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics, and the effect of food on pharmacokinetics of FTP-198 tablets at a single dose in healthy populations

A phase I clinical trial for evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics, and the effect of food on pharmacokinetics of FTP-198 tablets at a single dose in healthy populations

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051428
Enrollment
Unknown
Registered
2021-09-23
Start date
2021-09-20
Completion date
Unknown
Last updated
2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis

Interventions

Experimental group:FTP-198
control group:placebo

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 45 years, both male and female, and the BMI (weight (Kg)/height (m) square) is 19 to 24; 2. Qualified in the comprehensive physical examination, with normal blood and urine routine, liver and kidney function tests and electrocardiogram, and negative hepatitis B surface antigen; 3. Voluntarily take the test after understanding the content of the test, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those with a history of drug and food allergies, allergic diseases or allergic constitution; 2. Those with a history of chronic or organic diseases or existing heart, liver, kidney and blood system diseases; 3. Participated in other drug trials within 2 months before the trial; 4. Those who have participated in blood donation within 3 months before the test; 5. Those who have used any medicine (including traditional Chinese medicine) within 2 weeks; 6. Those who often use drugs, drink alcohol or smoke; those who have poor compliance.

Design outcomes

Primary

MeasureTime frame
plasma drug concentration;

Secondary

MeasureTime frame
pharmacodynamic parameter;

Countries

China

Contacts

Public ContactLuo Zhu

West China Hospital, Sichuan University

luozhu720@163.com+86 28 85423837

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026