A Single Ascending Dose Study of CD101 IV in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | July 2015 |
| End Date: | October 2015 |
A Phase 1, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects
A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of
CD101 IV
CD101 IV
This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending
single doses of CD101 Injection administered IV to healthy adult subjects. In this study,
subjects in 4 cohorts of 8 subjects, each will be randomized to receive single IV doses of
CD101 Injection or placebo. Dose levels of CD101 to be assessed will follow an ascending
single-dose regimen.
single doses of CD101 Injection administered IV to healthy adult subjects. In this study,
subjects in 4 cohorts of 8 subjects, each will be randomized to receive single IV doses of
CD101 Injection or placebo. Dose levels of CD101 to be assessed will follow an ascending
single-dose regimen.
Inclusion Criteria:
- Males surgically sterilized or using contraception,
- No significant findings on physical, ECG, clinical laboratory tests,
- BMI between 18.5 - 32.0,
- Must provide informed consent
Exclusion Criteria:
- Females of child bearing potential,
- Signs and or symptoms of an acute or chronic illness,
- Use of prescription medications within 28 days,
- Use of OTC, supplements, and herbals within 14 days,
- Current smoker
- Previous participation in a clinical study within 28 days
We found this trial at
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