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A Phase 1, Single-Center, Single-Blind, Placebo and Propofol Controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous (IV) Infusion Doses of ABP-700

A Phase 1, Single-Center, Single-Blind, Placebo and Propofol Controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous (IV) Infusion Doses of ABP-700 - ANVN-02 (CS0224)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41980
Enrollment
72
Registered
2014-07-21
Start date
2014-08-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anesthesia Not applicable

Interventions

The study will start with a screening. At the screening a physical examination will take place and a few other standard medical assessments will be performed (ECG, vital signs). Furthermore a blood

Sponsors

Annovation Biopharma, Inc. (a wholly owned subsidiary of The Medicines Company, Inc.)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy adult men and/or women between 18 and 45 years of age (inclusive)

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at medical research

Design outcomes

Primary

MeasureTime frame
Safety, PK and PD.

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)