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A Phase 1 Clinical Study in Healthy Participants

ConditionHV
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Argo Biopharmaceutical Co., Ltd.

About this trial

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-41012 in Healthy Participants

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Must have given written informed consent and be able to comply with all study requirements

Males or females aged 18 to 65 years old, inclusive, at the time of informed consent

Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 and body weight ≥50.0 kg.

APTT, PT, INR, and FXI activity within the normal range at screening

Disqualifiers

Any clinically significant chronic medical condition or clinically significant abnormality in laboratory parameters

Any skin condition and/or tattoo

Hospitalization for any reason within 60 days prior to screening

History or presence of cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • BW-41012 injection or Placebo

    Drug

    BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection

  • BW-41012 injection or Placebo

    Drug

    BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection

  • BW-41012 injection or Placebo

    Drug

    BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection

  • BW-41012 injection or Placebo

    Drug

    BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection

  • BW-41012 injection or Placebo

    Drug

    BW-41012 injection or Placebo dosage form is solution for injection and route of administration is subcutaneous injection

Treatment groups

40 Participants
are divided into 5 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention
Group E: Cohort 5Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary endpoints

Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and the changes in clinical laboratory tests

Time frame
up to 24 hours

Secondary outcomes

1

Secondary endpoints

Assessment the PK parameters change * Maximum observed plasma concentration (Cmax) * Time to maximum plasma concentration (Tmax) * Terminal elimination half-life (t1/2) * Area under the plasma concentration-time curve from time zero to the time of last measurable concentration (AUClast) * Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)

Time frame
up to 8 days
2

Secondary endpoints

Assessment the PD parameters change * Change from baseline in the level of factor XI * Change from baseline in the level of activated partial thromboplastin time

Time frame
up to 360days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Argo Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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