Clinical Trial: Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Randomized, Single Blind, Single Dose, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intradermal Dosage Form of BMT101 in Healthy
Brief Summary: Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers
Detailed Summary: A Randomized, Single Blind, Single Dose, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intradermal Dosage Form of BMT101 in Healthy Male Volunteers
Sponsor: Hugel
Current Primary Outcome: Safety Evaluation: Severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel [ Time Frame: 14 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: Cmax [ Time Frame: 4 days ]Determine peak whole blood concentration (Cmax)
- Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: AUC [ Time Frame: 4 days ]Determine area under the whole blood concentration versus time curve (AUC)
- Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: T½ [ Time Frame: 4 days ]Determine drug half-life in whole blood (T½)
Original Secondary Outcome: Same as current
Information By: Hugel
Dates:
Date Received: March 28, 2017
Date Started: April 2017
Date Completion: September 2017
Last Updated: April 27, 2017
Last Verified: April 2017