A Phase 1a Study of Thymosin Beta 4 in Healthy Volunteers
NCT ID: NCT04555824
Last Updated: 2020-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
2017-07-17
2018-06-20
Brief Summary
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Detailed Description
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In Phase 1A, Seven (7) cohorts of subjects (first two cohorts 2 subjects respectively, 10 subjects per cohort for next 5 cohorts) will administered one dose of NL005 or placebo in a 4:1 ratio. Dosing start at 0.05μg/kg and advance to 0.25, 0.5, 2, 5, 12.5, 25μg/kg.
NL005 or placebo administered as a single dose on Day 1. Safety parameters recorded on Study Days 1, 2, 5, 14, and 28. Evaluation of adverse events performed throughout the study. Pharmacokinetic samples obtained on Study Day 1. Blood samples collected for serum antibody determinations at Screening , Days 14 and 28.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Recombinant Human Thymosin β4 Dose 1 group
Two subjects in this group will receive NL005 for 0.05ug/kg respective in D1.
Recombinant Human Thymosin β4
Healthy subjects , were given a single intravenous dose of rh-Tβ4 in Day1.
Dose 2 groupRecombinant Human Thymosin β4
Two subjects in this group will receive NL005 for 0.25ug/kg respective in D1.
Recombinant Human Thymosin β4
Healthy subjects , were given a single intravenous dose of rh-Tβ4 in Day1.
Dose 3 groupRecombinant Human Thymosin β4
Eight subjects in this group will receive NL005 for 0.5ug/kg respective in D1.
Recombinant Human Thymosin β4
Healthy subjects , were given a single intravenous dose of rh-Tβ4 in Day1.
Dose 4 groupRecombinant Human Thymosin β4
Eight subjects in this group will receive NL005 for 2ug/kg respective in D1.
Recombinant Human Thymosin β4
Healthy subjects , were given a single intravenous dose of rh-Tβ4 in Day1.
Dose 5 groupRecombinant Human Thymosin β4
Eight subjects in this group will receive NL005 for 5ug/kg respective in D1.
Recombinant Human Thymosin β4
Healthy subjects , were given a single intravenous dose of rh-Tβ4 in Day1.
Recombinant Human Thymosin β4 Dose 6 group
Eight subjects in this group will receive NL005 for 12.5ug/kg respective in D1.
Recombinant Human Thymosin β4
Healthy subjects , were given a single intravenous dose of rh-Tβ4 in Day1.
Recombinant Human Thymosin β4 Dose 7 group
Eight subjects in this group will receive NL005 for 25ug/kg respective in D1.
Recombinant Human Thymosin β4
Healthy subjects , were given a single intravenous dose of rh-Tβ4 in Day1.
Placebo
Two subjects in each dose group（0.5/2/5/12.5/25ug/kg）were given placebo respective in D1. A total of 10 subjects were given placebos.
Placebo
Five cohorts, with 10 healthy subjects , were given a single intravenous dose of Placebo. Cohorts received ascending doses of either 0.5, 2,5,12.5 or 25 ug/kg in Day1.
Interventions
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Recombinant Human Thymosin β4
Healthy subjects , were given a single intravenous dose of rh-Tβ4 in Day1.
Placebo
Five cohorts, with 10 healthy subjects , were given a single intravenous dose of Placebo. Cohorts received ascending doses of either 0.5, 2,5,12.5 or 25 ug/kg in Day1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Between 18 and 50 years of age.
3. BMI between 19 and 28 kg/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. Medical history , physical examination, laboratory examinations are normal or not clinically significant abnormalities, and the investigator judges those who are qualified.
6. Voluntarily sign informed consent.
Exclusion Criteria
2. Active hepatitis b or c patients, carriers of hepatitis b virus.
3. HIV antibody test positive or syphilis spiral antibody test positive.
4. ADA tests positive.
5. Smoke more than 5 cigarettes a day, had a suspected or proven history of substance abuse, and consumed an average of more than 2 units of alcohol per day for 3 months (1 unit =12 ounces or 360mL beer, 5 ounces or 150mL liquor, 1.5 ounces or 45mL distilled liquor) or had a positive alcohol test.
6. Participated in another trial or used this drug within 3 months before inclusion.
7. Any other drug was used within two weeks before the trial.
8. There is a significant clinical history of allergy, especially for drugs, protein preparations and biological products, especially for rh-tβ4 or any of its ingredients.
9. Blood donation or blood loss was equal to or greater than 400 mL within three months prior to the trial.
10. Women who are pregnant or breast-feeding, or who are likely to become pregnant and do not use an acceptable method of contraception, or who have a positive pregnancy test and who do not use effective contraception or whose partner plans to give birth within six months.
11. Unable to tolerate venous blood collection.
12. There is no guarantee that smoking and taking grapefruit juice or any alcoholic and xanthine food and beverage (including chocolate, tea, coffee, cola, etc.) from 48 hours before administration to the last blood sample collection.
13. The investigator judges that the subject is unable to complete the study or otherwise considers that the subject's participation in the study may cause other injury.
18 Years
50 Years
ALL
Yes
Sponsors
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Beijing Northland Biotech. Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Shijitan Hospital
Beijing, , China
Countries
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Related Links
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Related Info
Other Identifiers
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NL005-Ⅰ-2015-1
Identifier Type: -
Identifier Source: org_study_id
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