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

A Randomized, Double-blind, Placebo-Controlled, Single Dose,Dose-escalation,Phase 1a Study of the Safety, Tolerability,Pharmacokinetics and the Potential Immunological Reaction of Recombinant Human Thymosin Beta4 in Chinese Healthy Volunteers

Sponsors

Lead Sponsor: Beijing Northland Biotech. Co., Ltd.

Source Beijing Northland Biotech. Co., Ltd.
Brief Summary

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 0.05, 0.25, 0.5, 2, 5, 12.5, 25μg/kg in Chinese healthy volunteers. 54 volunteers will be randomized to receive NL005 or placebo for 7 cohorts,administered iv by iv push on Day 1.

Detailed Description

This study is a randomized,double-blind,placebo-controlled, investigation to evaluate the safety, tolerability, pharmacokinetics and the potential immunological reaction of single of NL005 administered intravenously to healthy volunteers. 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.

Overall Status Completed
Start Date July 17, 2017
Completion Date June 20, 2018
Primary Completion Date February 20, 2018
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Maximum Tolerated Dose (MTD) . Day1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03. Day1
The Cmax of single ascending doses of rh-Tβ4. Day 1.
The Tmax of single ascending doses of rh-Tβ4. Day 1.
The MRT of single ascending doses of rh-Tβ4. Day 1.
The AUClast of single ascending doses of rh-Tβ4. Day 1.
The AUC0-inf of single ascending doses of rh-Tβ4. Day 1.
The t1/2 of single ascending doses of rh-Tβ4. Day 1.
The VZ of single ascending doses of rh-Tβ4. Day 1.
The CL of single ascending doses of rh-Tβ4. Day 1.
The potential immunological reaction (antibody formation) of single ascending doses of rh-Tβ4. Day 1、14、28.
Enrollment 54
Condition
Intervention

Intervention Type: Drug

Intervention Name: Recombinant Human Thymosin β4

Description: Healthy subjects , were given a single intravenous dose of rh-Tβ4 in Day1.

Other Name: rh-β4

Intervention Type: Other

Intervention Name: Placebo

Description: 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.

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria: 1. Chinese healthy volunteers(male or female). 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: 1. Physical examination, vital signs, ECG or laboratory examinations are abnormal (clinically significant ). 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Beijing Shijitan Hospital
Location Countries

China

Verification Date

May 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 8
Arm Group

Label: Recombinant Human Thymosin β4 Dose 1 group

Type: Experimental

Description: Two subjects in this group will receive NL005 for 0.05ug/kg respective in D1.

Label: Dose 2 groupRecombinant Human Thymosin β4

Type: Experimental

Description: Two subjects in this group will receive NL005 for 0.25ug/kg respective in D1.

Label: Dose 3 groupRecombinant Human Thymosin β4

Type: Experimental

Description: Eight subjects in this group will receive NL005 for 0.5ug/kg respective in D1.

Label: Dose 4 groupRecombinant Human Thymosin β4

Type: Experimental

Description: Eight subjects in this group will receive NL005 for 2ug/kg respective in D1.

Label: Dose 5 groupRecombinant Human Thymosin β4

Type: Experimental

Description: Eight subjects in this group will receive NL005 for 5ug/kg respective in D1.

Label: Recombinant Human Thymosin β4 Dose 6 group

Type: Experimental

Description: Eight subjects in this group will receive NL005 for 12.5ug/kg respective in D1.

Label: Recombinant Human Thymosin β4 Dose 7 group

Type: Experimental

Description: Eight subjects in this group will receive NL005 for 25ug/kg respective in D1.

Label: Placebo

Type: Placebo Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Dose Escalation for 7 Cohorts.

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov