NCT04555824·Phase 1·INTERVENTIONAL

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

Thymosin Beta-4 Other Completed

Status

Completed

Phase

Phase 1

Enrollment

54

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Recombinant Human Thymosin β4

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

OTHER

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.

Timeline

From registration to results.

First posted
Sep 21, 2020
Study start
Jul 17, 2017
Primary completion
Feb 20, 2018
Study completion
Jun 20, 2018
Results posted
Not reported
Registry updated
Sep 29, 2020

Outcomes

What the study measures.

Primary outcomes

Maximum Tolerated Dose (MTD) .

Time frame · Day1

Determine maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) by comprehensive evaluation of drug safety by adverse event observation, vital signs, physical examination, laboratory examination, electrocardiogram, etc. In this study, DLT was defined as liver, kidney, heart and mental nervous system toxicity of level 2 or above or blood system toxicity of level 3 or above and other systemic adverse events occurred within 14 days after drug administration, and the adverse events were judged to be related to the experimental drug use.If more than 3 (including 3) DLT cases are present in any dose group, the test should be terminated. The previous dose of this dose is considered the maximum tolerated dose (MTD).

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.

Time frame · Day1

Determine maximum tolerated dose (MTD) or dose-limiting toxicity (DLT) by comprehensive evaluation of drug safety by adverse event observation, vital signs, physical examination, laboratory examination, electrocardiogram, etc. All adverse events were determined according to NCI CTCAE4.03.CTCAE4.03 was classified into grades 1 to 5, in which grade 1 was mild adverse event and grade 5 was death due to adverse event.

The Cmax of single ascending doses of rh-Tβ4.

Time frame · Day 1.