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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051500

Enrollment

Registered

2023-04-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

None listed

Interventions

Intervention1: AntiPlatelet, AntiCoagulant (APAC): Single intravenous IV bolus dose at single-dose levels 1-3 and consecutive 5 days administration for Multiple dose level 4 Control Intervention1: NOT

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy subjects of either gender with >=18 and 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

Exclusion criteria: 1.Subjects with symptoms of fever or active infection, hemoglobin levels 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

India

Contacts

Public ContactDr Krunal Prajapati

Cadila Pharmaceuticals Limited

ashish.a@cadilapharma.co.in912714221481

Outcome results