A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/8/2014 |
| Start Date: | August 2014 |
| End Date: | November 2014 |
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Debio 1450 in Healthy Subjects
Debio 1450-103 is a study involving the use of a drug called Debio 1450. It is registered in
two parts (A and B). The primary purpose of Part B is to assess the safety, tolerability and
pharmacokinetics (PK) of multiple ascending doses of Debio 1450, administered sequentially
IV and orally, once or twice daily.
two parts (A and B). The primary purpose of Part B is to assess the safety, tolerability and
pharmacokinetics (PK) of multiple ascending doses of Debio 1450, administered sequentially
IV and orally, once or twice daily.
Inclusion Criteria:
- Meets protocol-specified criteria for qualification and/or contraception
- Is willing and able to remain confined in the study unit for the entire duration of
each treatment period and comply with restrictions related food, drink and
medications
- Voluntarily consents to participate and provides written informed consent prior to
any protocol-specific procedures
Exclusion Criteria:
- Has a history or current use of over-the-counter medications, dietary supplements, or
drugs (including nicotine and alcohol) outside protocol-specified parameters
- Has signs, symptoms or history of any condition that, per protocol or in the opinion
of the investigator, might compromise: 1) the safety or well-being of the participant
or study staff; 2) the safety or well-being of the participant's offspring (such as
through pregnancy or breast-feeding); 3) the analysis of results
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