Skip to content

Tolerance, pharmacokinetics and pharmacodynamics of PEG-INF-alpha 2b in healthly volunteers: A Randomized, Single center, drug control, Open-Label study

Study for tolerance, pharmacokinetics and pharmacodynamics of PEG-INF-alpha 2b

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPQ-14005299
Enrollment
Unknown
Registered
2014-10-09
Start date
1990-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Chronic hepatitis B and C

Interventions

control group:PegIntron subcutaneously
control group:PEGASYS subcutaneously
Test group:hypodermic

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) the age of 18 ~ 40 years old, gender parity; (2) according to bmi = weight (kg)/height 2 (m2), within the scope of the 19 ~ 24; (3) comprehensive physical examination qualified: including blood routine, urine routine, stool routine, blood biochemistry, liver, kidney function, blood glucose, blood lipids, enzymology, electrolyte), myocardial marker (CK - MB, myoglobin, troponin T check), hepatitis b, hepatitis c virus (HCV) markers, early HIV screening, we, immunity, 12 lead ecg, X-ray chest X-ray examination is normal; Urine HCG detection (female subjects, such as necessary); (4) a careless, brain, liver, kidney, gastrointestinal tract, blood, metabolic abnormalities, mental illness, genetic diseases, such as the history; (5) addicted to cigarettes, alcohol, and agreed to during the test ban smoking, drinking; (6) voluntary participation.

Exclusion criteria

Exclusion criteria: (1) health check is not eligible; (2) the history of drug allergy or a history of allergy, heart, liver, kidney, digestive tract, blood, metabolism, mental disorders, history of genetic diseases such as chronic physical diseases and medical history related to test drugs; (3) test within 2 weeks before had any medications (including traditional Chinese medicine); (4) within 1 month before the test subjects participated in any drugs; (5) experiment participated in 3 month before donating blood or blood; (6) test before 3 months used drugs that have known for a certain organs; (7) addicted to cigarettes, alcohol, drug abuse, (8) test during pregnancy may and pregnancy, nursing mothers.

Design outcomes

Primary

MeasureTime frame
ECG;Blood;Urine;Stool;Blood biochemistry;Thyroid function;DIC routine coagulation;Immune inspection;Cardiac markers;

Secondary

MeasureTime frame
Vital Signs;

Countries

China

Contacts

Public ContactZheng Li
18980601950@163.com+86 028-85423655

Outcome results

None listed

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