Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771

Phase-I, Double-blind, Randomized, Placebo-controlled Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771 in Adult Healthy Human Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05640531

Enrollment

Registered

2022-12-07

Start date

2011-12-01

Completion date

2012-06-27

Last updated

2022-12-07

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

Conditions

Bioavailability

Brief summary

The present study is planned to assess the safety and pharmacokinetic profile in normal healthy subjects in US for WCK 771 with doses ranging from 600 mg to 1000 mg BID for 5 days. In the proposed Phase I MAD study, a subject will be administered 600mg, 800mg, and 1000mg WCK 771 BID for 5 days (Ten doses) or an identical placebo as intravenous infusion.

Interventions

DRUGWCK 771 IV Infusion

subjects will receive intravenous infusion of WCK 771

OTHERPlacebo IV Infusion

subjects will receive matching placebo intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Have a Body Mass Index (BMI) between 18 and 32 (both inclusive), calculated as weight in kg/height in m2 * Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations and ECG recordings

Exclusion criteria

* Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs * Any history or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system * Use of any prescription drug within 14 days prior to start of the study (check-in) and nonprescription drug within 7 days prior to start of study (check-in)

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the pharmacokinetics of multiple doses of WCK 771	Day 5	Measuring Cmax Maximum observed plasma concentration.
To evaluate the safety & tolerability of multiple doses of WCK 771	Day 12	By monitoring the adverse events reported

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026