Primary objective: To determine the safety and tolerability of single ascending i.v. doses of T20K administered to healthy male subjects up to detectable levels of T20K within the defined dose rangeSecondary objective: To explore the plasma profile…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and tolerability parameters including adverse events (AEs), vital signs,
physical examination, 12-lead ECG, telemetry, local tolerance and clinical
laboratory values after single ascending dose administration.
Secondary outcome
Plasma concentrations of T20K.
Background summary
Cyclotide-based peptides appear to be good candidates for pharmaceutical drug
development for treatment of diseases with an overreactive immune system. The
reversible T-cell inhibition mechanism of cyclotides makes them very appealing
from an efficacy and safety perspective, and it is likely that such products
will hold a very competitive position on the multiple sclerosis (MS) market.
Study objective
Primary objective:
To determine the safety and tolerability of single ascending i.v. doses of
T20K administered to healthy male subjects up to detectable levels of T20K
within the defined dose range
Secondary objective:
To explore the plasma profile of T20K at the first dose level where T20K can
be quantified following i.v. doses of T20K.
Study design
This study is an interventional, single site, placebo-controlled, double-blind,
randomized, single ascending dose study.
Intervention
T20K or placebo, single dose.
Study burden and risks
Since the study is being executed in healthy volunteers, there are no
anticipated benefits of the IMP. Please see the IMPD for further information.
Adelgatan 21
Malmö 211 22
SE
Adelgatan 21
Malmö 211 22
SE
Listed location countries
Age
Inclusion criteria
1. Male subject between 18 and 55 years, inclusive, at the time of screening.
2. Healthy as determined by the Investigator, based upon a medical evaluation
including medical history, physical examination and clinical laboratory testing
performed at Screening.
3. A body weight of *60 kg and a body mass index (BMI) *18.0 kg/m2 and * 30.0
kg/m2 at Screening.
Exclusion criteria
1. Evidence of active and/or chronic disease that, in the Investigator*s
opinion, could interfere with the study procedures or could adversely affect
the safety of the subject or could affect the safety and/or pharmacokinetic
(PK) evaluations.
2. History of drug abuse.
3. Positive urine drug screen and/or positive alcohol breath test at Screening
or on Day -1.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-002235-29-NL |
| CCMO | NL70279.056.19 |