A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-30

Study Completion Date

2019-07-26

Brief Summary

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The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or placebo 0.5, 2.0,5.0μg/kg in Chinese healthy volunteers.30 volunteers will be randomly assigned to one of three groups to receive either NL005 or placebo for 10 consecutive days.

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Detailed Description

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This study was a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability pharmacokinetics and potential immune responses of multiple NL005 intravenous administration.

Three groups of 30 subjects will receive an NL005 or placebo dose of 0.5μg/kg 2.0 μg/kg and 5.0 μg/kg for 10 consecutive days at a ratio of 4:1.

While observing the safety of the subjects in each dose group, about 5mL of venous blood was collected for the ADA study in healthy subjects 14 days and 28 days after the first administration of the drug.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dose Escalation for 3 Cohorts.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Recombinant Human Thymosin β4 0.5ug/kg

10 subjects in this group will receive NL005 for 0.5ug/kg respective.Continuous administration for 10 days.

Group Type EXPERIMENTAL

Recombinant Human Thymosin β4

Intervention Type DRUG

Healthy subjects , were given a dose of rh-Tβ4 for ten consecutive days.

Recombinant Human Thymosin β4 2.0ug/kg

10 subjects in this group will receive NL005 for 2.0ug/kg respective.Continuous administration for 10 days.

Group Type EXPERIMENTAL

Recombinant Human Thymosin β4

Intervention Type DRUG

Healthy subjects , were given a dose of rh-Tβ4 for ten consecutive days.

Recombinant Human Thymosin β4 5.0ug/kg

10 subjects in this group will receive NL005 for 5.0ug/kg respective.Continuous administration for 10 days.

Group Type EXPERIMENTAL

Recombinant Human Thymosin β4

Intervention Type DRUG

Healthy subjects , were given a dose of rh-Tβ4 for ten consecutive days.

Placebo

Two subjects in each dose group (0.5/2/5ug/kg) were given placebo for 10 days.A total of six participants were given a placebo.

Group Type OTHER

Placebo

Intervention Type OTHER

3 cohorts, with 6 healthy subjects , were given a dose of Placebo for ten consecutive days. Cohorts received ascending doses of either 0.5,2.0 or 5.0 ug/kg .

Interventions

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Recombinant Human Thymosin β4

Healthy subjects , were given a dose of rh-Tβ4 for ten consecutive days.

Intervention Type DRUG

Placebo

3 cohorts, with 6 healthy subjects , were given a dose of Placebo for ten consecutive days. Cohorts received ascending doses of either 0.5,2.0 or 5.0 ug/kg .

Intervention Type OTHER

Other Intervention Names

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rh-β4

Eligibility Criteria

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Inclusion Criteria

1. Chinese healthy volunteers（male or female）.
2. Between 18 and 50 years of age.
3. Female subjects should weigh no less than 45 kg and male subjects should weigh no less than 50 kg.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. Ability to communicate normally with medical staff, understand research requirements and comply with hospital regulations.
6. Voluntarily sign informed consent.

Exclusion Criteria

1. Physical examination vital signs electrocardiogram and laboratory examination are not done or any result is judged to be clinically significant abnormal (judged by clinician).
2. ADA tests positive.
3. Smoking more than 5 cigarettes a day for the previous 3 months, or no guarantee to stop smoking during the trial.
4. Previous history of substance abuse or drug screening test positive.
5. Alcohol intake averaged more than 2 units per day (1 unit = 360mL beer,150mL wine or 45mL 40% alcohol liquor) or alcohol test positive in the first 3 months of inclusion.
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. Female subjects who are pregnant or breast-feeding, or who are likely to become pregnant without using an acceptable method of contraception, or who are positive for a pregnancy test, and male subjects who are not using effective contraception or whose partner has a family planning plan within six months of the end of the trial.
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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes