A Phase-I clinical study of intravenous AntiPlatelet, AntiCoagulant (APAC) in healthy subjects.

Phase 1

• Registration Number: CTRI/2023/04/051500
• Lead Sponsor: Cadila Pharmaceutical Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Healthy subjects of either gender with >=18 and <=45 years of age.

2.Subjects able to understand and provide the written informed consent.

3.Subject willing to follow study schedules and all requirements of the study, in the PI/investigatorâ??s opinion.

4.Female subjects of childbearing potential having a negative urine pregnancy test prior to first dose of APAC.

Exclusion Criteria

1.Subjects with symptoms of fever or active infection, hemoglobin levels <= 11 g/dL, thrombocytopenia, (platelet count < 100,000/cmm).

2.Subjects with a history of known sensitivity to heparin.

3.Subjects with an abnormal APTT, PT, TT, ACT, platelet aggregation studies, fibrinogen, D-dimer, anti-Factor IIa activity, anti-Factor Xa activity and/or abnormal or prolonged ROTEM, VWF:Ag, FVIII or AT-III value(s) at Screening.

4.Subject taking any prescription drugs or over the counter (OTC) medications, including herbal and ayurvedic medications at Screening.

5.Subjects with any other medical condition (a bleeding disorder), including any evidence of HIT, which in the opinion of the PI/investigator, should exclude them from the study.

6.Concurrent involvement in any other clinical study with an investigational drug or device, or participation in a clinical study within 30 days prior to entering the study.

7.Female subjects who are pregnant, lactating or of childbearing potential and unwilling or unable to use adequate contraception.

8.Subjects who for any reason, in the PI/investigatorâ??s opinion, are unsuitable for enrolment into the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish the safety and tolerability profile of an ascending single dose (OD) and multiple dose IV administration of APAC in healthy subjects.Timepoint: To evaluate DLT based on AE/SAE observed during 24 hour after dosing with APAC

Secondary Outcome Measures

Name	Time	Method
To evaluate the PD effect of ascending single doses and multiple dose IV administration of APAC in healthy subjects.Timepoint: Assessment of pharmacodynamic parameters at baseline and at predefined time-points during 24 hour after dosing at single dose levels 1-3 and at multiple dose level 4.