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 ]

Assess severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel


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