A Phase 1 randomized, double-blind study to investigate the single and multiple dose safety, tolerability and pharmacokinetics of WCK 4282 (FEP-TAZ) upon intravenous administrations in healthy volunteers

A Phase 1 randomized, double-blind study to investigate the single and multiple dose safety, tolerability and pharmacokinetics of WCK 4282 (FEP-TAZ) upon intravenous administrations in healthy volunteers - W-4282-103 (CS0252)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43462

Enrollment

Registered

2016-01-13

Start date

2016-01-27

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

Bacterial infections

Interventions

The study will start with a screening visit. During the screening visit standard medical assessments including safety laboratory tests (blood draw, urine collection), an alcohol breath test, urine d

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy Male or female, between 18 and 65 years of age both (inclusive)

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at medical research.

Design outcomes

Primary

Measure	Time frame
Safety, tolerability and pharmacokinetics.	—

Secondary

Measure	Time frame
N.A.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)