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Bioavailability 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
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000107
Enrollment
Unknown
Registered
2008-06-11
Start date
2005-09-01
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

RT group:subcutaneously injected reference preparation rhGM-CSF150 ug in the first cycle, after one week orally administered rhGM-CSF 480 ug in the scond cycle
TR group:orally administered rhGM-CSF 480 ug in the first cycle, after one week subcutaneously injected reference preparation rhGM-CSF150 ug in the scond cycle

Sponsors

Insititute of Biochemistry, College of Life Science, Zhejiang Sci-Tech University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. healthy male subjects; 2. the age of 18 to 40-year-old; 3. weight over 50 kg, body mass index [BMI = weight (kg) / height (m) 2] at 19 ~ 25 kg/m2 range; 4. no history of organ diseases and history of drug allergy; 5. non-drug abusers; 6. non-alcoholic drinks and tobacco habits; 7. no-taking drug treatment within the past two weeks; 8. with good communication between researchers, to comply with the requirements of the entire study; 9. signed informed consent.

Exclusion criteria

Exclusion criteria: 1. participated other clinical trials in last 2 months; 2. donated blood during the trial period or within last 1 month; 3. did not accept physical examination.

Design outcomes

Primary

MeasureTime frame
rhGM-CSF concentration in blood plasma;

Countries

China

Contacts

Public ContactYaozhou Zhang
wenpingzhang@zstu.edu.cn+86 0571 86843198

Outcome results

None listed

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