A phase I study to evaluate the tolerability, pharmacokinetics and preliminary pharmacodynamics of Lyophilized recombinant human keratinocyte growth factor in healthy subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13004043

Enrollment

Unknown

Registered

2013-10-10

Start date

2013-01-08

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

severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support

Interventions

1:Single intravenous bolus injection of lyophilized

2:Single intravenous bolus injection of lyophilized recombinant human keratinocyte growth factor 5ug/Kg

3:Single intravenous bolus injection of lyophilized recombinant human keratinocyte growth factor 20ug/Kg

4:Single intravenous bolus injection of lyophilized recombinant human keratinocyte growth factor 40ug/Kg

5:Single intravenous bolus injection of lyophilized recombinant human keratinocyte growth factor 60ug/Kg

6:Single intravenous bolus injection of lyophilized recombinant human keratinocyte growth factor 80ug/Kg

7:Single intravenous bolus injection of lyophilized recombinant human keratinocyte growth factor 120ug/Kg

8:Single intravenous bolus injection of lyophilized recombinant human keratinocyte growth factor 180ug/Kg

M1:Daily single intravenous bolus injection of lyophilized recombinant human keratinocyte growth factor 20ug/Kg for 3 consecutive days

M2:Daily single intravenous bolus injection of lyophilized recombinant human keratinocyte growth factor 40ug/Kg for 3 consecutive days

M3:Daily single intravenous bolus injection of lyophilized recombinant human keratinocyte growth factor 60ug/Kg for 3 consecutive days

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Healthy subjects, half men and half women; 2. Age 18-45 years; 3. Weight: BMI within the range of 19-24 kg/m2; 4. The following items are in normal range, or abnormal without clinical significant, including routine blood tests, routine urine tests, blood biochemical test(including electrolytes), Amylase, Lipase, pancreas amylase, urine trace protein test, ECG, abdominal ultrasonography, chest radiograph. Women with the urine pregnancy tests negative; 5. Volunteers with signed ICF.

Exclusion criteria

Exclusion criteria: 1. Pregnant woman (Urine pregnancy test positive) or nursing mothers; 2. Using medical intervention including herbal medicine in the past 2 weeks; 3. With history of mental illness, addictive, drug abuse, smoke and alcohol use; 4. With disease history of chronic cardiovascular, liver, kidney, gastrointestinal, endocrine, immune, respiratory; 5. With history of drug or food allergies; 6. With blood donation or blood sample collection in other clinical studies in the past 3 months; 7. With oral ulceration, herpes stomatitis, oral candidiasis, a history of severe gingivitis in the past 30 days, 8. With history of pancreatitis; 9. Subjects with fertility requirements within six months. Children bearing women taking non-instrumental contraceptive measures; 10. Men with history of epididymitis; 11. Women with history of ovulation pain; 12. With history of Cataract.

Design outcomes

Primary

Measure	Time frame
Tolerance;Pharmacokinetic;	—

Secondary

Measure	Time frame
Pharmacodynamic;	—

Countries

China

Contacts

Public ContactJia Miao

Genemen Biotech (Suzhou) Co., Ltd.

miaosiyi1971@163.com+86 028-85422622

Outcome results

None listed

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