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

NCT05640531 | Completed Phase 1 FDA Drug

• 1 other identifier: WCK771/P-I/MD/08
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety & tolerability of multiple doses of WCK 771

  By monitoring the adverse events reported

  Day 12

• To evaluate the pharmacokinetics of multiple doses of WCK 771

  Measuring Cmax Maximum observed plasma concentration.

  Day 5

Study Arms (2)

WCK 771

EXPERIMENTAL

WCK 771 600mg, 800mg, and 1000mg WCK 771 BID. Dosage form : IV Infusion

Drug: WCK 771 IV Infusion

Placebo infusion

PLACEBO COMPARATOR

Matching Placebo administered as IV infusion

Other: Placebo IV Infusion

Interventions

WCK 771 IV Infusion DRUG

subjects will receive intravenous infusion of WCK 771

WCK 771

Placebo IV Infusion OTHER

subjects will receive matching placebo intravenous infusion

Placebo infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wockhardt: lead

Study Sites (1)

PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200

Austin, Texas, 78744, United States

Location

Study Officials

• Ashima Bhatia, MD

  Wockhardt Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: December 7, 2022
• Study Start: December 1, 2011
• Primary Completion: February 7, 2012
• Study Completion: June 27, 2012
• Last Updated: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)