NL-OMON48273
Completed
Not Applicable
Phase I, Single-Center, Randomized, Placebo-Controlled, Double-Blinded Study with Single Ascending Doses, Evaluating the Safety and Tolerability of T20K, Administered by a 1-hr IV Infusion in Healthy Male Volunteers - CS0312 Cyxone
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cyxone AB
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\.
Outcomes
Primary Outcomes
Not specified
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