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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018991
Enrollment
Unknown
Registered
2018-10-20
Start date
2018-10-18
Completion date
Unknown
Last updated
2018-10-22

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

Conditions

myocardial damage

Interventions

Group 1:0.5µg/kg dosage per day for 10 consecutive days
Group 2:2µg/kg dosage per day for 10 consecutive days
Group 3:5µg/kg dosage per day for 10 consecutive days

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 of female subjects should not be less than 45 kg, weight of male subjects should not be less than 50 kg, body mass index (BMI) 19-28kg/m2[BMI= weight/height 2] (including 19 and 28kg/m2); 4) Good health condition, no history of unintentional, liver, kidney, digestive tract, immune system, nervous system, mental and metabolic abnormality, no family history of tumor; 5) Ability to communicate with medical staff, understand research requirements and comply with hospital management regulations; 6) Fully understand the purpose, nature and method of the trial and sign the informed consent voluntarily.

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