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Tolerance and pharmacokinetics studyof recombinant human thymosin beta4 (NL005) for single administration in Chinese healthy subjects

Tolerance and pharmacokinetics studyof recombinant human thymosin beta4 (NL005) for single administration in Chinese healthy subjects

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IID-17011983
Enrollment
Unknown
Registered
2017-07-13
Start date
2017-07-11
Completion date
Unknown
Last updated
2017-07-17

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

Conditions

myocardial damage

Interventions

Group 1:0.05µg/kg
Group 2:0.05µg/kg
Group 3:0.5µg/kg
Group 4:2.0µg/kg
Group 5:5.0µg/kg
Group 6:12.5µg/kg
Group 7:25µg/kg

Sponsors

Beijing Shijitan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1) Chinese healthy subjectshalf males and half females; 2) Aged from 18 to 50 years old; 3) Weight =50 kg, BMI range from 19 to 28kg/m2[BMI=weight/height2]; 4) Good healthy, withoutcardiac, liver, kidney, gastrointestinal tract, immune system, nervous system mental disorderor metabolic abnormalities, without a family history of tumor; 5) Medical history, physical examination, laboratory examinationor other related examinationresults are normal or abnormal but investigator estimate the result is No clinical significance; 6) Subject owns the ability to communicate with hospital staffs and comply with the relevant hospital management regulations; 7) Subject is Able to communicate with theinvestigators, understand and comply with trial requirements; 8) Voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Physical examination, Vital signs test laboratory examinationElectrocardiogramresultisabnormaland investigator estimate the result is clinical significance; 2) Active hepatitis B or hepatitis C patients, hepatitis B virus carriers; 3) HIV antibody test positive or syphilis spiral antibody test positive; 4) ADA test positive; 5) Smoking is more than five cigarettes per dayalcohol intake (1 unit = 12 ounces or 360 mL of beer, 5 ounces or 150 mL of white wine, 1.5 ounces or 45 mL of distilled liquor) for 3 months per day for more than 5 persons per day, suspected or indeed having a history of drug abuse Or alcohol test positive; 6) Participated in a drug trial or used in this test drugs in three months; 7) Any other drugs have been used within two weeks before the start of the trial; 8) There is a significant history of allergic reactions, especially drugs, protein preparations, biological products, allergic history, especially for rh-Tß4 or any of the ingredients allergies; 9) Blood donation or blood loss was equal to or more than 400 mL within three months of the trial; 10) Pregnant or breastfeeding women, or women who are pregnant and may not have an acceptable contraceptive method, or who have a positive pregnancy test and who have not taken effective contraceptive measures or their spouse plan within six months of birth; 11) Can not tolerate vein blood collection; 12) It is not guaranteed to ban smoking and ban on grapefruit juice or any alcohol and xanthine-containing foods and beverages (including chocolate, tea, coffee, cola, etc.) from 48 hours before the last administration to the last blood; 13) The investigator judged that the subject was unable to complete the study or that the subject was involved in other situations that could cause harm in this study.

Design outcomes

Primary

MeasureTime frame
Blood Pressure;Pulse;Respiration;ECG;Temperature;Blood Routine Examination;Routine Urine Examination;Blood Biochemical;

Countries

China

Contacts

Public ContactXinghe Wang

Beijing Shijitan Hospital Capital Medical University

wangxinghe@yahoo.com+86 10 63926401

Outcome results

None listed

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