Status:
COMPLETED
Study Of Safety, Tolerability And Pharmacokinetics Of Subcutaneous Doses Of TA-46
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
Brief Summary
TA-46 single- and multiple-ascending dose study in healthy volunteers to investigate safety and PK. The protocol is conducted in four parts; Part A - Single Ascending doses of TA46 Part B - Multiple A...
Detailed Description
This is a single-center, 34-part clinical study in healthy subjects. Part A This is a single-center, double-blind, randomized, placebo-controlled, single ascending dose study in healthy subjects. The...
Eligibility Criteria
Inclusion
- Age : 21-55 years, inclusive, at screening
- Weight : maximum weight of 100 kg
- Normal height without any growth complications during childhood
- Healthy as determined by screening assessments
Exclusion
- Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would, in the opinion of the PI, pose an unacceptable risk to the subject in this study
- Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis)
- Participation in an investigational drug or device study within 3 months prior to (the first) drug administration in the current study
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2019
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04410809
Start Date
January 19 2018
End Date
November 27 2019
Last Update
June 1 2020
Active Locations (1)
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1
PRA
Groningen, Netherlands, 9728 NZ