An Ascending Multiple 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: | September 2015 |
| End Date: | January 2016 |
A Phase 1, Randomized, Double-Blind, Multiple-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects
A multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics
of CD101 Injection in Healthy Subjects.
of CD101 Injection in Healthy Subjects.
This is a Phase 1, single-center, prospective, randomized, double-blind study of multiple
ascending doses (MAD) of CD101 Injection administered IV to healthy adult subjects. In this
study, subjects in 3 cohorts of 8 subjects each will be randomized to receive multiple IV
doses of CD101 Injection or placebo infusions. Dose levels of CD101 Injection to be assessed
will follow an ascending multiple-dose regimen.
ascending doses (MAD) of CD101 Injection administered IV to healthy adult subjects. In this
study, subjects in 3 cohorts of 8 subjects each will be randomized to receive multiple IV
doses of CD101 Injection or placebo infusions. Dose levels of CD101 Injection to be assessed
will follow an ascending multiple-dose regimen.
Inclusion Criteria:
- Men must be surgically sterilized or using contraception,
- No significant findings on physical exam, ECG, clinical laboratory tests,
- Body mass index (BMI) between 18.5 and 32.0 kg/m2, inclusive
- Must provide written informed consent
Exclusion Criteria:
- Females of child bearing potential
- Signs and or symptoms of acute illness or chronic disease
- 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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