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Clinical safety of orally administered recombinant hGM-CSF

Phase I, II, III clinical trial of orally administered recombinant hGM-CSF

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNRC-08000105
Enrollment
Unknown
Registered
2008-06-06
Start date
2004-02-01
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

volunteers

Interventions

300ug group:orally administered recombinant hGM-CSF
600ug group:orally administered recombinant hGM-CSF
120ug group:orally administered recombinant hGM-CSF
900ug group:orally administered recombinant hGM-CSF
720ug group:orally administered recombinant hGM-CSF
240 ug(twice daily) group:orally administered recombinant hGM-CSF(twice dail)
120ug(twice daily) group:orally administered recombinant hGM-CSF(twice dail)

Sponsors

Second Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 30 Years

Inclusion criteria

Inclusion criteria: Male and female healthy volunteers, aged 20 to 30 years old and weigh at 45 ~ 75 kg within the past subjects are unmotivated, liver, kidney, gastrointestinal and metabolic disorders, neuropsychiatric diseases, such as medical history and drug allergies History, smoke-free, wine hobby, and within three months without participating in any drug test and using any other drugs. Healthy volunteers signed informed consent and were conducted a comprehensive history and physical examination and laboratory tests including blood pressure, heart rate and body temperature measurements, blood examination, urine analysis, blood biochemistry, HBAg determination and ECG, etc. Successful applicants have access to trial.

Exclusion criteria

Exclusion criteria: Pregnancy or breast-feeding women, drug allergy or a history of allergic disease; spirit of defects; bleeding family or personal history have gastrointestinal and urinary tract reproductive, cardiovascular, nervous system, liver, kidney, lung disease and metabolic history; smoke (> 10 / day) wine hobby; a history of drug abuse.

Design outcomes

Primary

MeasureTime frame
safet;

Countries

China

Contacts

Public ContactYaozhou Zhang
wenpingzhang@zstu.edu.cn+86 0571 86843199

Outcome results

None listed

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