NL-OMON37679CompletedNot Applicable
A DOUBLE-BLIND, ASCENDING SINGLE AND MULTIPLE DOSE, SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC AND FOOD EFFECT STUDY OF EVP 6308 IN HEALTHY VOLUNTEERS. - EVP-6308 single and multiple ascending dose study.
EnVivo Pharmaceuticals, Inc.0 sites70 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Age : SAD part (Groups 1-3) and MAD part (Groups 4-7): 18-65 years, inclusive;
- •BMI : 18.0 * 28.0 kg/m2, inclusive
- •Gender : healthy male or female subjects; female subjects must be of non-childbearing potential (either surgically
- •sterilized or at least 1 year post-menopausal)
Exclusion Criteria
- •Suffering from : hepatitis B. cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of the study. In case of donating blood or significant loss of blood within 60 days of the start of drug dosing.
Investigators
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